U.S. patent number 8,945,163 [Application Number 12/416,546] was granted by the patent office on 2015-02-03 for methods and devices for cutting and fastening tissue.
This patent grant is currently assigned to Ethicon Endo-Surgery, Inc.. The grantee listed for this patent is Robert P. Gill, Christopher J. Hess, Michael A. Murray, Darrel M. Powell, James W. Voegele, William B. Weisenburgh, II. Invention is credited to Robert P. Gill, Christopher J. Hess, Michael A. Murray, Darrel M. Powell, James W. Voegele, William B. Weisenburgh, II.
United States Patent |
8,945,163 |
Voegele , et al. |
February 3, 2015 |
Methods and devices for cutting and fastening tissue
Abstract
Methods and devices are provided for cutting and fastening
tissue. In one embodiment, a surgical device can be used to at
least partially transect a stomach by not cutting and/or not
fastening a portion of tissue engaged in an end effector located at
the device's distal end. A portion of the stomach can be engaged by
the end effector, and the end effector can be actuated to cut
and/or to apply one or more fasteners to tissue engaged in a distal
portion of the end effector but not to cut and/or apply fasteners
to tissue engaged in a proximal portion of the end effector. In a
similar way, the surgical device can be used in any surgical
procedure in which it is desired to cut and/or fasten a distal
portion of tissue engaged by the end effector but not a proximal
portion of tissue engaged by the end effector.
Inventors: |
Voegele; James W. (Cincinnati,
OH), Weisenburgh, II; William B. (Maineville, OH), Hess;
Christopher J. (Cincinnati, OH), Murray; Michael A.
(Bellevue, KY), Gill; Robert P. (Mason, OH), Powell;
Darrel M. (Cincinnati, OH) |
Applicant: |
Name |
City |
State |
Country |
Type |
Voegele; James W.
Weisenburgh, II; William B.
Hess; Christopher J.
Murray; Michael A.
Gill; Robert P.
Powell; Darrel M. |
Cincinnati
Maineville
Cincinnati
Bellevue
Mason
Cincinnati |
OH
OH
OH
KY
OH
OH |
US
US
US
US
US
US |
|
|
Assignee: |
Ethicon Endo-Surgery, Inc.
(Cincinnati, OH)
|
Family
ID: |
42309704 |
Appl.
No.: |
12/416,546 |
Filed: |
April 1, 2009 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20100256634 A1 |
Oct 7, 2010 |
|
Current U.S.
Class: |
606/170; 606/142;
227/180.1 |
Current CPC
Class: |
A61B
17/07207 (20130101); A61B 17/0218 (20130101); A61B
17/00234 (20130101); A61B 2017/00278 (20130101); A61B
2017/00818 (20130101); A61B 2017/3466 (20130101); A61B
2017/07285 (20130101); A61B 2017/320052 (20130101); A61B
90/50 (20160201) |
Current International
Class: |
A61B
17/072 (20060101); A61B 17/125 (20060101) |
Field of
Search: |
;227/175.1,180.1
;606/139,167,170,219,205-209 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
0568383 |
|
Nov 1993 |
|
EP |
|
0646358 |
|
Apr 1995 |
|
EP |
|
950376 |
|
Oct 1999 |
|
EP |
|
1350476 |
|
Oct 2003 |
|
EP |
|
1731105 |
|
Dec 2006 |
|
EP |
|
1927319 |
|
Jun 2008 |
|
EP |
|
2710270 |
|
Mar 1995 |
|
FR |
|
2006320750 |
|
Nov 2006 |
|
JP |
|
WO-2005087112 |
|
Sep 2005 |
|
WO |
|
WO-2005094432 |
|
Oct 2005 |
|
WO |
|
WO-2006019592 |
|
Feb 2006 |
|
WO |
|
WO-2006019723 |
|
Feb 2006 |
|
WO |
|
WO-2006035446 |
|
Apr 2006 |
|
WO |
|
WO-2007119232 |
|
Oct 2007 |
|
WO |
|
WO-2008024502 |
|
Feb 2008 |
|
WO |
|
WO-2008093313 |
|
Aug 2008 |
|
WO |
|
WO-2008149332 |
|
Dec 2008 |
|
WO |
|
WO2009/039510 |
|
Mar 2009 |
|
WO |
|
WO-2009039510 |
|
Mar 2009 |
|
WO |
|
Other References
Extended European Search Report for EP10250704.3 dated Dec. 3, 2010
(7 pages). cited by applicant .
Ahmad G, Duffy JM, Phillips K, Watson A., "Laparoscopic Entry
Techniques" Cochrane Database Syst Rev., (2):CD006583, Apr. 16,
2008. cited by applicant .
Bucher P, Pugin F, Morel P., "Single Port Access Laparoscopic Right
Hemicolectomy" Int J Colorectal Dis., Jul. 8, 2008. cited by
applicant .
Canes D, Desai MM, Aron M, Haber GP, Goel RK, Stein RJ, Kaouk JH,
Gill IS., "Transumbilical Single-Port Surgery: Evolution and
Current Status" Eur Urol., Jul. 14, 2008. cited by applicant .
Gill IS, Canes D, Aron M, Haber GP, Goldfarb DA, Flechner S, Desai
MR, Kaouk JH, Desai MM., "Single Port Transumbilical (E-Notes)
Donor Nephrectomy" Journal Urol., 180(2):637-41; Aug. 2008. cited
by applicant .
Goel RK, Kaouk JH., "Single Port Access Renal Cryoablation (SPARC):
A New Approach" Eur Urol. Jun. 2008;53(6):1204-9. Epub Mar. 18,
2008. cited by applicant .
Johnston D , Dachtler J , Sue-Ling HM, King RF, Martin I. G,
Roderick F.G. "The Magenstrasse and Mill Operation for Morbid
Obesity" Obesity Surgery, Apr. 2003. cited by applicant .
K. Sumiyama, C. Gostout, E.Rajan, T.Bakken, M.Knipschield, S.Chung,
P.Cotton, R.Hawes, A.Kalloo, A.Kalloo, S.Kantsevoy and P.Pasricha
"Transgastric Cholecystectomy: Transgastric Accessibility to The
Gallbladder Improved with the SEMF Method and a Novel Multibending
Therapeutic Endoscope" Gastrointestinal Endoscopy , vol. 65, Issue
7, Jun. 2007. cited by applicant .
Kaouk JH, Haber GP, Goel RK, Desai MM, Aron M, Rackley RR, Moore C,
Gill IS., "Single-port Laparoscopic Surgery in Urology: Iniitial
Experience", Urology., 71(1):3-6., Jan. 2008. cited by applicant
.
Kaouk JH, Palmer JS., "Single-port Laparoscopic Surgery: Initial
Experience in Children for Varicocelectomy" BJU Int.;102(1):97-9.
Epub Mar. 5, 2008. cited by applicant .
Ponsky LE, Cherullo EE, Sawyer M, Hartke D., "Single Access Site
Laparoscopic Radical Nephrectomy: Initial Clinical Experience" J
Endourol., 22(4):663-6, Apr. 2008. cited by applicant .
Ponsky TA, Lukish JR., "Single Site Laparoscopic Gastrostomy with a
4-mm Bronchoscopic Optical Grasper" J Pediatric Surgery,
43(2):412-4, Feb. 2008. cited by applicant .
Product Brochure "Access the Future of Laparoscopic Surgery"
Advanced Surgical Concepts Limited, Inc. cited by applicant .
Rane A, Rao P, Rao P. Single-port-access Nephrectomy and Other
Laparoscopic Urologic Procedures Using a Novel Laparoscopic Port
(R-port), Urology. (2):260-3; discussion, Epub May 12, 2008. cited
by applicant .
Vassallo C, et al. "The Super-Magenstrasse and Mill Operation with
Pyloroplasty: Preliminary Results", Obesity Surgery, 17, Aug. 2007.
cited by applicant .
Web Page www.websurg.com/notes/videos.php
<http://www.websurg.com/notes/videos.php>, Screenshots videos
"Notes Hybrid Sleeve Gastrectomy Performed During Course" Vix, MD;
Solano, MD; Asakuma, MD, Feb. 2008. cited by applicant .
Web Page www.websurg.com/notes/videos.php
<http://www.websurg.com/notes/videos.php>, Screenshots videos
"Transvaginal Hybrid Notes Sleeve Gastrectomy Porcine Model" Vix,
MD; Solano, MD; Asakuma, MD, Dec. 2007. cited by applicant.
|
Primary Examiner: Severson; Ryan
Assistant Examiner: Papeika; Rachel S
Attorney, Agent or Firm: Mintz Levin Cohn Ferris Glovsky and
Popeo, P.C.
Claims
What is claimed is:
1. A surgical device, comprising: first and second jaws configured
to be movable relative to one another and configured to engage
tissue therebetween, the first jaw having a first tissue-engaging
surface and the second jaw having a second tissue-engaging surface,
the first and second tissue-engaging surfaces facing each other
substantially along entire length thereof, and least one of the
first and second jaws including a surface feature extending from an
interior surface thereof; and a knife configured to translate
between proximal and distal ends of the first and second jaws, the
knife being movable between a proximal region of the first and
second tissue-engaging surfaces of the first and second jaws and a
distal region of the first and second tissue-engaging surfaces of
the first and second jaws, tissue not being cut throughout the
proximal region and tissue being cut in the distal region, the
knife being in a first position in the proximal region and in a
second position in the distal region, and the knife including a
complementary feature formed therein that is complementary to the
surface feature and is configured to engage the surface feature to
move the knife between the first and second positions, wherein the
proximal region comprises at least about 20% of a total length
extending between the proximal and distal ends of the first and
second jaws.
2. The device of claim 1, wherein the knife is configured to pivot
between the first and second positions as the knife translates
through the first and second jaws.
3. The device of claim 2, wherein the complementary feature
includes a cut-out formed in the knife that is configured to allow
the knife to pivot between the first and second positions.
4. The device of claim 1, wherein the knife is configured to
translate in a distal to proximal direction through the first and
second jaws to cut tissue.
5. The device of claim 1, wherein the knife is configured to
translate in a proximal to distal direction through the first and
second jaws to cut tissue.
6. The device of claim 1, wherein the second position is rotated
about 90.degree. from the first position.
7. The device of claim 1, wherein, when the complementary feature
includes a cut-out formed in the knife.
8. The device of claim 7, wherein, when the knife is in the second
position, the cut-out is formed in a distal-facing side of the
knife cutting element.
9. The device of claim 7, wherein, when the knife is in the second
position, the cut-out is formed in a proximal-facing side of the
knife.
10. The device of claim 1, wherein the proximal region comprises up
to 70% of the total length extending between the proximal and
distal ends of the end effector.
11. A surgical device, comprising: an elongate shaft; an end
effector coupled to a distal end of the elongate shaft, the end
effector configured to engage tissue, and the end effector having a
longitudinal slot formed in a distal region thereof but not in a
proximal region thereof such that the longitudinal slot extends
along a partial longitudinal length of the end effector; and a
cutting blade configured to translate between proximal and distal
ends of the end effector and throughout entireties of the proximal
and distal regions, the cutting blade having a first position in
the proximal region of the end effector in which tissue is not cut
and having a second position in the distal region of the end
effector in which tissue is cut, the cutting blade being movable
between the first and second positions, and the cutting blade
extending through the longitudinal slot in the distal region.
12. The device of claim 11, wherein the cutting blade is configured
to translate in a distal to proximal direction along the end
effector to cut tissue.
13. The device of claim 11, wherein the cutting blade is configured
to rotate between the first and second positions.
14. The device of claim 11, further comprising a cam element
configured to move the cutting blade from one of the first and
second positions to another of the first and second positions
during translation of the cutting blade along the end effector.
15. The device of claim 11, wherein the proximal region comprises
at least about 20% of a total length extending between the proximal
and distal ends of the end effector.
16. The device of claim 11, wherein the proximal region has a
longitudinal length at least as long as a longitudinal length of
the distal region.
17. The device of claim 11, wherein the proximal region has a
length in a range of about 20% to 70% of a total length extending
between the proximal and distal ends of the end effector.
Description
FIELD OF THE INVENTION
The present invention relates to methods and devices for cutting
and fastening tissue, and in particular to methods and devices for
performing gastroplasties.
BACKGROUND OF THE INVENTION
Obesity is becoming a growing concern, particularly in the United
States, as the number of obese people continues to increase and
more is learned about the negative health effects of obesity.
Morbid obesity, in which a person is 100 pounds or more over ideal
body weight, in particular poses significant risks for severe
health problems. Accordingly, a great deal of attention is being
focused on treating obese patients. Surgical procedures to treat
morbid obesity have included gastric bypasses (stomach stapling),
adjustable gastric banding, and vertical banded gastroplasty and
sleeve gastrectomies (removal of all or a portion of the stomach).
Such surgical procedures have increasingly been performed
laparoscopically. Reduced post-operative recovery time, markedly
decreased post-operative pain and wound infection, and improved
cosmetic outcome are well established benefits of laparoscopic
surgery, derived mainly from the ability of laparoscopic surgeons
to perform an operation utilizing smaller incisions of the body
cavity wall. However, multiple abdominal incisions are often
required in such obesity treatment procedures, thereby increasing
chances for undesirable post-operative consequences such as
cosmetic scarring.
Gastroplasties have become increasingly favored by surgeons and
patients for treating obesity, as well as for treating stomach
diseases such as cancer where a portion of the stomach is removed,
because gastroplasties do not leave any foreign material in a
patient and do not require a complicated intestinal bypass.
Instead, the stomach's volume is reduced through partial division
of the stomach, thereby leaving a stomach "sleeve" between the
esophagus and intestine. A laparoscopic gastroplasty procedure
generally involves insufflation of the abdominal cavity with carbon
dioxide gas to a pressure of around 15 millimeters of mercury (mm
Hg). The abdominal wall is pierced and a 5-10 mm in diameter
straight tubular cannula or trocar is inserted into the abdominal
cavity. A laparoscopic telescope connected to an operating room
monitor is used to visualize the operative field and is placed
through one of the trocar(s). Laparoscopic instruments are placed
through two or more additional trocars for manipulation by the
surgeon and surgical assistant(s). Thus, such laparoscopic
procedures can require multiple instruments to be introduced into a
patient through multiple, potentially scarring incisions and/or can
result in interference between instruments near each other. The
placement of two or more standard cannulas and laparoscopic
instruments in the abdomen next to each other and/or placement of
two or more instruments into the abdomen through the same incision
creates a so-called "chopstick" effect, which describes
interference between the surgeon's hands, between the surgeon's
hands and the instruments, and between the instruments. This
interference greatly reduces the surgeon's ability to perform a
described procedure. Further, in a Magenstrasse and Mill
gastroplasty procedure in which only a portion of the stomach is
cut to form the stomach sleeve, a starting location for the stomach
sleeve must be identified, which can require additional
instrumentation and surgical time.
Accordingly, there remains a need for methods and devices for
cutting and fastening tissue that minimize patient recovery time,
improve cosmetic outcome, reduce the "chopstick" effect, and
minimize surgical procedure duration.
SUMMARY OF THE INVENTION
The present invention generally provides methods and devices for
cutting and fastening tissue. In one embodiment, a surgical device
is provided that includes first and second jaws that can be movable
relative to one another and that can engage tissue therebetween.
The device also includes a cutting element that can translate
between a proximal end to a distal end of the first and second
jaws. The cutting element can be movable between a first position
in a proximal region of the first and second jaws in which tissue
is not cut and a second position in a distal region of the first
and second jaws in which tissue is cut.
The device can have any number of variations. For example, the
cutting element can pivot between the first and second positions as
the cutting element translates through the first and second jaws.
The cutting element can include a cut-out formed therein that can
allow the cutting element to pivot between the first and second
positions. For another example, at least one of the first and
second jaws can include a cam element that can move the cutting
element from one of the first and second positions to another of
the first and second positions as the cutting element translates
through the first and second jaws. For still another example, the
cutting element can translate in a distal to proximal direction
through the first and second jaws to cut tissue, and/or the cutting
element can translate in a distal to proximal direction through the
first and second jaws to cut tissue. For yet another example, the
proximal region can comprise at least 50% of a total length
extending between the proximal and distal ends of the first and
second jaws.
In another embodiment, a surgical device is provided that includes
an elongate shaft, and an end effector that is coupled to a distal
end of the elongate shaft and that can engage tissue. The device
also includes a cutting element that can translate between a
proximal end to a distal end of the end effector. The cutting
element can be movable between a first position in a proximal
region of the end effector in which tissue is not cut and a second
position in a distal region of the end effector in which tissue is
cut.
The device can vary in any number of ways. For example, the cutting
element can translate in a distal to proximal direction along the
end effector to cut tissue. As another example, the cutting element
can rotate between the first and second positions. As yet another
example, the device can include a cam element that can move the
cutting element from one of the first and second positions to
another of the first and second positions during translation of the
cutting element along the end effector. As still another example,
the proximal region can comprise at least 50% of a total length
extending between the proximal and distal ends of the end
effector.
In another aspect, a surgical method is provided that includes
advancing a surgical device into a body cavity of a patient,
engaging a portion of a stomach of the patient between first and
second jaws of an end effector at a distal end of the surgical
device, and translating a cutting element along proximal and distal
regions of the first and second jaws such that tissue engaged in
the proximal region is not cut by the cutting element and such that
tissue engaged in the distal region is cut by the cutting
element.
The method can have any number of variations. For example, during
translation of the cutting element along the first and second jaws,
the method can include moving the cutting element relative to the
first and second jaws between a first position in the proximal
region of the first and second jaws and a second position in the
distal region of the first and second jaws for another example,
translating a cutting element along proximal and distal regions of
the first and second jaws can include moving the cutting element in
a proximal to distal direction along the first and second jaws. For
yet another example, prior to engaging a portion of the stomach
between first and second jaws of the end effector, the method can
include positioning a proximal end of the end effector
substantially at an antrum of the stomach and positioning a distal
end of the end effector a distance proximal to an angle of His of
the stomach. For still another example, translating a cutting
element along proximal and distal regions of the first and second
jaws can include cutting the stomach from a location proximal to an
antrum of the stomach and through an angle of His of the stomach.
For another example, translating a cutting element along proximal
and distal regions of the first and second jaws can include forming
a first slit formed in an anterior wall of the stomach and a
second, separate slit formed in a posterior wall of the stomach.
For yet another example, advancing a surgical device into a body
cavity of a patient can include advancing the surgical device
through one of an abdominal access hole formed in the patient or a
vaginal access hole formed in the patient.
In another embodiment, a surgical device is provided that includes
first and second jaws movable relative to one another and having a
distal region that is configured to cut and to deliver a plurality
of fasteners to tissue engaged in the distal region of the first
and second jaws, and a proximal region that is configured to engage
tissue without fastening and without cutting the tissue.
The device can have any number of variations. For example, the
device can include a plurality of fasteners disposed in the distal
region of the first and second jaws. The device can also include a
cartridge disposed in one of the first and second jaws and having a
distal region that contains the plurality of fasteners therein, and
a proximal region that is free of the fasteners. In one embodiment,
the proximal region can comprise at least about 20% of a total
length extending between proximal and distal ends of the first and
second jaws. The device can also include a cutting element that can
continuously translate through the proximal and distal regions and
cut tissue engaged in the distal region and not cut tissue engaged
in the proximal region. The cutting element can be movable between
a first position in the proximal region and a second position
rotated from the first position in the distal region, where the
cutting element in the first position cannot cut tissue engaged by
the first and second jaws and in the second position can cut tissue
engaged by the first and second jaws. In some embodiments, at least
one of the first and second jaws can include a cam element that can
move the cutting element from one of the first and second positions
to another of the first and second positions during translation of
the cutting element through the first and second jaws.
In another embodiment, a surgical device is provided that includes
an elongate shaft and an end effector coupled to a distal end of
the elongate shaft. The end effector can have a distal region that
can deliver a plurality of fasteners to tissue engaged therein, and
a proximal fastener-free region that can engage tissue. The device
can also include a cutting element that can translate along the end
effector to cut tissue engaged by the distal region without cutting
tissue engaged by the proximal fastener-free region of the end
effector.
In one embodiment, the cutting element can be movable between a
first position in the proximal region in which tissue is not cut
and a second position in the distal region in which tissue is cut.
The device can also include a cam element that can move the cutting
element from one of the first and second positions to another of
the first and second positions during translation of the cutting
element along the end effector. The cutting element can rotate
between the first and second positions during translation of the
cutting element along the end effector. The cutting element can
also translate in a proximal to distal direction or in a distal to
proximal direction along the end effector to cut tissue. In another
embodiment, a longitudinal length of the proximal region can be
greater than a longitudinal length of the distal region.
In another aspect, a surgical method is provided that includes
advancing a surgical device into a body cavity of a patient,
engaging anterior and posterior walls of a stomach of the patient
with an end effector on a distal end of the surgical device such
that a folded edge of the stomach is positioned in a proximal
region of the end effector, and actuating the surgical device to
form a transection in the stomach without transecting the folded
edge of the stomach.
The method can have any number of variations. For example,
actuating the surgical device can include moving a cutting element
through the proximal region of the end effector without cutting the
folded edge and the anterior and posterior walls of the stomach
engaged by the proximal region of the end effector, and moving the
cutting element through a distal region of the end effector to cut
the anterior and posterior walls of the stomach engaged by the
distal region of the end effector. As another example, actuating
the surgical device can include delivering a plurality of fasteners
to the anterior and posterior walls of the stomach engaged by a
distal region of the end effector without delivering any fasteners
to the folded edge and the anterior and posterior walls of the
stomach engaged by the proximal region of the end effector. As yet
another example, forming a transection in the stomach without
transecting the folded edge of the stomach can include transecting
the stomach from a location proximal to an antrum of the stomach
and through an angle of His of the stomach. As still another
example, forming a transection in the stomach without transecting
the folded edge of the stomach can include forming a first slit
formed in the anterior wall and a second, separate slit formed in
the posterior wall. As another example, advancing a surgical device
into a body cavity of a patient can include advancing the surgical
device through one of an abdominal access hole formed in the
patient or a vaginal access hole formed in the patient.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be more fully understood from the following
detailed description taken in conjunction with the accompanying
drawings, in which:
FIG. 1 is a perspective partially transparent view of one
embodiment of a patient having an access hole formed in an
abdominal wall of the patient;
FIG. 2 is a perspective partially transparent view of the patient
of FIG. 1 having a second access hole formed in the umbilicus of
the patient;
FIG. 3 is a perspective partially transparent view of the patient
of FIG. 2 having a third access hole formed in the abdominal wall
of the patient;
FIG. 4 is a perspective partially transparent view of one
embodiment of a patient having an access hole formed in a vaginal
wall of the patient;
FIG. 5 is a perspective partially transparent view of one
embodiment of a liver retracting device retracting a liver of a
patient;
FIG. 6 is a perspective partially transparent view of one
embodiment of a dissecting device dissecting tissue from a stomach
of a patient;
FIG. 7 is a perspective partially transparent view of one
embodiment of a vaginally inserted dissecting device dissecting
tissue from a stomach of a patient with a grasper tensioning the
tissue;
FIG. 8 is a perspective partially transparent view of one
embodiment of a dissecting device dissecting tissue from a stomach
of a patient with a grasper tensioning the tissue and advanced
through an opening in a digestive tract of the patient;
FIG. 9 is a perspective partially transparent view of one
embodiment of a patient having an access hole formed in a vaginal
wall of the patient, a first abdominal port formed at an umbilicus
of the patient, and a second abdominal port formed in an abdominal
wall of the patient;
FIG. 10 is a perspective view of one embodiment of a tunnel formed
underneath a stomach of a patient;
FIG. 11 is a perspective partially transparent view of one
embodiment of a sizer advanced into a stomach of a patient;
FIG. 12 is a perspective partially transparent view of one
embodiment of a transecting device transecting a stomach of a
patient and inserted into the patient through an access hole formed
in a vaginal wall of the patient;
FIG. 13 is a perspective partially transparent view of one
embodiment of a transecting device transecting a stomach of a
patient and inserted into the patient through a multiple port
access device disposed in an abdomen of the patient;
FIG. 14 is a perspective view of one embodiment of a transecting
device positioned in an initial position to transect a portion of a
stomach of a patient;
FIG. 15 is a perspective view of one embodiment of a sealed opening
formed by the transecting device of FIG. 14;
FIG. 16 is a perspective view of one embodiment of a staple
cartridge having a proximal, cut-free and fastener-free region;
FIG. 17 is a perspective view of one embodiment of a cutting
assembly coupled to a staple cartridge having a proximal, cut-free
and fastener-free region;
FIG. 18 is another perspective view of the cutting assembly and
staple cartridge of FIG. 17;
FIG. 19 is a top view of the cutting assembly and staple cartridge
of FIG. 17;
FIG. 20 is a side view of the cutting assembly and staple cartridge
of FIG. 17;
FIG. 21 is an exploded view of the cutting assembly of FIG. 17;
FIG. 22 is a perspective view of the cutting assembly of FIG. 17
with a cutting element of the cutting assembly in a cutting
position;
FIG. 23 is a perspective view of another embodiment of a cutting
assembly coupled to a staple cartridge having a proximal, cut-free
and fastener-free region;
FIG. 24 is a side view of the cutting assembly and staple cartridge
of FIG. 23;
FIG. 25 is a top view of the cutting assembly and staple cartridge
of FIG. 23;
FIG. 26 is an exploded view of the cutting assembly of FIG. 23;
FIG. 27 is a side view of the cutting assembly of FIG. 23 with a
cutting element of the cutting assembly in an initial, non-cutting
position;
FIG. 28 is another side view of the cutting assembly of FIG. 23
with the cutting element in the initial, non-cutting position;
FIG. 29 is a partial cutaway perspective view of the cutting
assembly and staple cartridge of FIG. 23 with the cutting element
in an initial, non-cutting position and engaging a cam member in
the staple cartridge;
FIG. 30 is a partial cutaway perspective view of the cutting
element of FIG. 29 rotating around the cam member from the initial,
non-cutting position to a cutting position;
FIG. 31 is a partial cutaway perspective view of the cutting
element of FIG. 30 in the cutting position rotated around the cam
member;
FIG. 32 is a partial cutaway perspective view of the cutting
element of FIG. 31 distally advanced in the cartridge in the
cutting position;
FIG. 33 is a partial cutaway side view of one embodiment of a
cutting assembly coupled to an end effector having a proximal,
cut-free and fastener-free region and including a staple cartridge
and an anvil, with a cutting element of the cutting assembly in an
initial, non-cutting position;
FIG. 34 is a partial cutaway end view of the cutting assembly and
the staple cartridge of FIG. 33;
FIG. 35 is a partial cutaway end view of the cutting assembly of
FIG. 33 distally translating through the staple cartridge with a
cutting element of the cutting assembly moving from the initial,
non-cutting position to a cutting position;
FIG. 36 is a partial cutaway end view of the cutting assembly of
FIG. 34 distally translating through the staple cartridge with the
cutting element in the cutting position;
FIG. 37 is a partial cutaway side view of another embodiment of a
cutting assembly coupled to an end effector having a proximal,
cut-free and fastener-free region and including a staple cartridge
and an anvil, with a cutting element of the cutting assembly in an
initial, non-cutting position;
FIG. 38 is a partial cutaway end view of the cutting assembly and
the staple cartridge of FIG. 37;
FIG. 39 is a partial cutaway end view of the cutting assembly of
FIG. 37 distally translating through the staple cartridge with a
hinge of the cutting assembly bending to move the cutting element
from the initial, non-cutting position to a cutting position;
FIG. 40 is a partial cutaway end view of the cutting assembly of
FIG. 39 distally translating through the staple cartridge with the
cutting element in the cutting position;
FIG. 41 is a partial side view of one embodiment of a cutting
assembly having a cutting element coupled to a pusher bar with a
flexible connector element;
FIG. 42 is a partial cutaway side view of one embodiment of a
cutting element disposed in an initial, non-cutting position in a
distal end of a pair of jaws having a proximal, cut-free and
fastener-free region, and a pusher bar distally moving through the
jaws toward the cutting element;
FIG. 43 is a partial cutaway side view of the pusher bar of FIG. 42
coupled to the cutting element and moving proximally through the
jaws with the cutting element in a cutting position;
FIG. 44 is a partial cutaway side view of the pusher bar of FIG. 43
coupled to the cutting element and moving proximally through the
jaws with the cutting element in the non-cutting position;
FIG. 45 is a side view of one embodiment of a cutting element
including two pivotably connected members;
FIG. 46 is a partial side view of one embodiment of a pusher bar
configured to couple to the cutting element of FIG. 45;
FIG. 47 is a partial side view of the pusher bar of FIG. 46 coupled
to the cutting element of FIG. 45, with the cutting element in a
cutting position;
FIG. 48 is a perspective view of one embodiment of a transecting
device transecting a portion of a stomach of a patient with a sizer
positioned in the stomach;
FIG. 49 is a perspective view of one embodiment of a transected
stomach;
FIG. 50 is a perspective view of one embodiment of a transecting
device having an extended length end effector positioned in an
initial position to transect a portion of a stomach of a
patient;
FIG. 51 is a partial side view of the transecting device of FIG.
50;
FIG. 52 is a partial distal end view of the end effector of FIG.
51;
FIG. 53 is a partial side view of the end effector of FIG. 51;
and
FIG. 54 is a perspective view of one embodiment of an end effector
of a transecting device having a plurality of notches formed
therein.
DETAILED DESCRIPTION OF THE INVENTION
Certain exemplary embodiments will now be described to provide an
overall understanding of the principles of the structure, function,
manufacture, and use of the devices and methods disclosed herein.
One or more examples of these embodiments are illustrated in the
accompanying drawings. Those skilled in the art will understand
that the devices and methods specifically described herein and
illustrated in the accompanying drawings are non-limiting exemplary
embodiments and that the scope of the present invention is defined
solely by the claims. The features illustrated or described in
connection with one exemplary embodiment may be combined with the
features of other embodiments. Such modifications and variations
are intended to be included within the scope of the present
invention.
Various exemplary methods and devices are provided for cutting and
fastening tissue. A person skilled in the art will appreciate that
while the methods and devices are described in connection with a
gastroplasty, the methods and devices disclosed herein can be used
in numerous surgical procedures. By way of non-limiting example,
the devices can be used in laparoscopic procedures, in which the
devices are introduced percutaneously. The methods and devices can
also be used in open surgical procedures. Furthermore, the surgical
devices can be configured to pass through any portion of a body,
but in an exemplary embodiment, the surgical devices are configured
to pass through an abdominal access hole or a vaginal access
hole.
In one embodiment, a method of performing a gastroplasty includes
gaining access to a stomach of a patient through one or more
openings formed in one or more of the patient's digestive tract,
abdominal wall, and vaginal wall. In an exemplary embodiment, the
methods and devices are used to perform a Magenstrasse and Mill
procedure in which only a portion of the stomach is transected.
Various instruments can be inserted through various access holes in
the patient to perform certain steps, such as tensioning and
cutting tissue, sizing and transecting the stomach, viewing the
surgical site, etc. In an exemplary embodiment, a surgical device
is provided that can be used to at least partially transect the
stomach. The device can have an end effector that can engage
tissue, and that can be actuated to cut and/or to apply one or more
fasteners to tissue engaged in a distal portion of the end effector
without cutting and/or applying fasteners to tissue engaged in a
proximal portion of the end effector. In this way, in a
Magenstrasse and Mill procedure where the stomach is not fully
transected between the stomach's angle of His and the stomach's
pylorus, a device that does not cut and/or fasten tissue engaged in
a proximal region of an end effector can be used to engage the
stomach's antrum without cutting the antrum and instead can cut and
fasten tissue apart from the antrum, i.e., tissue engaged in the
distal portion of the device. Use of the device can reduce the need
to measure, calculate, mark, etc., the stomach 40 to determine a
starting location for the stomach transection because the device
can generally predetermine the transection's starting location by a
proximal cut-free and/or fastener-free region with a predetermined
length. In a similar way, the surgical device can be used in any
surgical procedure in which it is desired to cut and/or fasten a
distal portion of tissue engaged by the end effector but not a
proximal portion of tissue engaged by the end effector.
A patient can be prepared for a gastroplasty surgical procedure in
any way, as will be appreciated by a person skilled in the art. For
example, the patient can be fully sedated or consciously sedated
for the procedure. Non-limiting embodiments of a conscious sedation
system can be found in U.S. Patent Publication No. 2006/0042636
filed on Jun. 21, 2005 and entitled "Oral Nasal Cannula," U.S. Pat.
No. 6,807,965 issued Oct. 26, 2004 and entitled "Apparatus And
Method For Providing A Conscious Patient Relief From Pain And
Anxiety Associated With Medical Or Surgical Procedures," U.S. Pat.
No. 7,201,734 issued Apr. 10, 2007 and entitled "Apparatus For Drug
Delivery In Association With Medical Or Surgical Procedures," U.S.
Pat. No. 7,247,154 issued Jul. 24, 2007 and entitled "Method For
Drug Delivery In Association With Medical Or Surgical Procedures,"
which are hereby incorporated by reference in their entireties.
In one exemplary embodiment of a gastroplasty procedure illustrated
in FIG. 1, an abdominal opening or access hole 12 is formed in an
abdominal wall 14 of a patient 10. During the gastroplasty, the
patient 10 is preferably positioned as shown in a reclined,
substantially horizontal lithotomy position on an examination table
18 to provide clear access to the patient's abdominal region. FIG.
1 and other figures discussed herein are simplified for ease of
presentation and do not always illustrate the patient 10 and/or
devices present at a given moment in a surgical procedure, such as
devices shown in one or more previously described figures and any
additional necessary equipment, e.g., patient monitoring equipment,
safety devices, video monitors, etc. Furthermore, the gastroplasty
is described as performed by a surgeon, but as will be appreciated
by a person skilled in the art, one or more medical professionals,
e.g., surgeons, surgical assistants, nurses, etc., can perform any
one or more portions of the procedure. Also, while a female patient
is illustrated, the patient 10 be male or female.
As shown in FIG. 1, the abdominal opening or access hole 12 can be
formed in the abdominal wall 14, although an access hole can be
used and/or be formed anywhere in the patient 10. The abdominal
access hole 12 can be in the form of a substantially circular
otomy, or it can be a percutaneous incision. A person skilled in
the art will appreciate that the term "otomy" as used herein is
intended to encompass an opening or access hole that is configured
to accommodate an access device with a retractor or other device
positionable in the access hole having an outer diameter in the
range of about 15 to 35 mm, e.g., about 25.4 mm (about 1 inch). A
person skilled in the art will also appreciate that the term
"percutaneous opening" or "percutaneous access hole" as used herein
is intended to encompass a relatively small opening or access hole
in a patient that preferably has a diameter in a range of about 3
to 5 mm.
The abdominal access hole 12 can be formed in any way, as will be
appreciated by a person skilled in the art. As illustrated, the
abdominal access hole 12 is formed using a trocar 16. The trocar 16
can include any cannula configured to incise tissue and having a
cannulated interior through which a surgical instrument can be
passed into a patient through the incised tissue. The trocar 16 can
include an optical tip configured to provide visualization of the
abdominal wall 14 as the trocar 16 is passed therethrough, for
example using a scoping device with a viewing element located
thereon, e.g., a laparoscope 20, that is inserted into the trocar
16. The laparoscope 20 can be inserted into the trocar 16 at any
time, including during penetration through tissue or after the
trocar 16 penetrates the abdominal wall 14. A person skilled in the
art will also appreciate that any one or more scoping devices used
in the gastroplasty can each include any surgical device having a
viewing element, e.g., a lens, located thereon. Non-limiting
examples of a scoping device include an endoscope, a laparoscope, a
gastroscope, and a colonoscope. The trocar 16 can be configured to
allow a rigid or flexible surgical instrument, e.g., a grasper, a
cutting instrument, a scoping device, etc., to be passed
therethrough and into the patient's abdominal cavity. A person
skilled in the art will appreciate that the term "grasper" as used
herein is intended to encompass any surgical instrument that is
configured to grab and/or attach to tissue and thereby manipulate
the tissue, e.g., forceps, retractors, movable jaws, magnets,
adhesives, stay sutures, etc.
In one embodiment, a scoping device inserted into the patient 10
can include one or more distal, flexible joints that can help
orient the scoping device inside the patient 10. Non-limiting
embodiments of flexible joints on a surgical device can be found in
U.S. patent application Ser. No. 12/242,333 filed Sep. 30, 2008 and
entitled "Methods And Devices For Performing Gastrectomies And
Gastroplasties," U.S. patent application Ser. No. 12/242,353 filed
Sep. 30, 2008 and entitled "Methods And Devices For Performing
Gastrectomies And Gastroplasties," and U.S. patent application Ser.
No. 12/242,381 filed Sep. 30, 2008 and entitled "Methods And
Devices For Performing Gastroplasties Using A Multiple Port Access
Device," which are hereby incorporated by reference in their
entireties. In general, the flexible joint(s) can be configured to
flex or bend. The flexible joint(s) can be passively actuated,
e.g., moveable when abutted by one or more adjacent structures,
and/or actively actuated, e.g., through manipulation of a
mechanical and/or manual actuation mechanism. The flexible joint(s)
can be configured to bend in a single direction when actuated, and
the single direction can be selectively chosen, e.g., left, right,
up, down, etc. If a surgical device includes a plurality of
flexible joints, each of the flexible joints can be configured to
be independently actuated in any direction same or different from
any of the other flexible joints of the surgical device. The
actuation mechanism can be configured to control the amount of
movement in a chosen direction. The flexible joint(s) can be formed
in any way, same or different from one another, as will be
appreciated by a person skilled in the art. For non-limiting
example, the flexible joint(s) can be made from a flexible
material, can include one or more features formed therein to
facilitate flexibility, e.g., a plurality of cut-outs, slots, etc.,
and/or can be formed from a plurality of linkages that are movably
coupled to one another. In an alternate embodiment, a scoping
device can have two or more flexible joints each at different
locations along its longitudinal axis, with or without use of a
sleeve, to allow the scoping device to bend in at least two
directions relative to the scoping device's longitudinal axis. A
non-limiting example of a multibending scoping device is the
R-Scope XGIF-2TQ260ZMY available from Olympus Corp. of Tokyo,
Japan.
Optionally, one or more openings or access holes in addition to the
abdominal access hole 12 can be formed in the patient's abdominal
wall 14. Each additional abdominal access hole can have any size,
shape, and configuration, but in an exemplary embodiment, the
additional abdominal access hole(s) are each percutaneous openings.
Any of the additional abdominal access hole(s) can be formed before
and/or after the abdominal access hole 12, but in an exemplary
embodiment, any additional abdominal access hole(s) are formed
after the abdominal access hole 12 to allow prior insufflation of
the patient's abdominal cavity using a surgical device inserted
through the abdominal access hole 12, as discussed further
below.
FIG. 2 illustrates one embodiment of an additional abdominal
opening or access hole 22 formed in the patient 10 in addition to
the abdominal access hole 12 having the trocar 16 positioned
therein. The additional abdominal opening 22 can have any size,
shape, and configuration, but in an exemplary embodiment, the
additional abdominal access hole 22 is an otomy an is located
substantially at the patient' umbilicus. Smaller and fewer body
cavity incisions can generally improve a patient's recovery time
and reduce pain, so it can be advantageous to perform an operation
utilizing only a single abdominal incision, such as one in the
navel. The umbilicus is the thinnest and least vascularized, and a
well-hidden, area of the abdominal wall 14. An umbilical incision
can be easily enlarged, e.g., in order to eviscerate a larger
specimen, without significantly compromising cosmesis and without
increasing the chances of wound complications. The additional
abdominal opening 22 can be formed in any way, as will be
appreciated by a person skilled in the art. A multiple port access
device 24 having two or more sealing ports through which surgical
instruments can be inserted can be positioned in the abdominal wall
14 following creation of the additional abdominal access hole 22 in
any way such as by using a cutting instrument, e.g., a needle
knife, a scalpel, a hook knife, etc. The multiple port access
device 24 can have any configuration, but non-limiting embodiments
of a multiple port access device can be found in previously
mentioned U.S. patent application Ser. No. 12/242,381 filed Sep.
30, 2008 and entitled "Methods And Devices For Performing
Gastroplasties Using A Multiple Port Access Device" and in U.S.
Patent Publication No. 2006/0247673 filed Apr. 5, 2006 and entitled
"Multi-port Laparoscopic Access Device," U.S. patent application
Ser. No. 12/242,765 filed Sep. 30, 2008 and entitled "Surgical
Access Device," U.S. patent application Ser. No. 12/242,711 filed
Sep. 30, 2008 and entitled "Surgical Access Device with Protective
Element," U.S. patent application Ser. No. 12/242,721 filed Sep.
30, 2008 and entitled "Multiple Port Surgical Access Device," and
U.S. patent application Ser. No. 12/242,726 filed Sep. 30, 2008 and
entitled "Variable Surgical Access Device," which are hereby
incorporated by reference in their entireties.
FIG. 3 shows another embodiment where, in addition to the abdominal
access hole 12 and the additional abdominal access hole 22, a
second additional abdominal opening or access hole 26 is formed in
the patient's abdominal wall 14 to provide access to the patient's
abdominal cavity. The second additional abdominal opening 26 can
have any size, shape, and configuration, but in an exemplary
embodiment, the second additional access hole 26 has a size, shape,
and configuration substantially the same as the abdominal access
hole 12. The additional abdominal access holes 22, 26 can be formed
in any order with respect to one another and with respect to the
abdominal opening 12 with the trocar 16 positioned therein. The
abdominal access holes 12, 22, 26 can be positioned anywhere
through the patient's abdominal wall 14, but as illustrated, the
percutaneous abdominal access holes 12, 26 can be substantially
laterally aligned on opposed sides of the patient's abdomen. The
access hole 22 having the multiple port access device 24 positioned
therein can, as illustrated, be non-laterally aligned with and be
located between the percutaneous abdominal access holes 12, 26,
e.g., in the umbilicus. In this way, a grasper can be inserted
through at least one of the percutaneous abdominal access holes 12,
26 and can allow tissue to be tensioned in the patient 10 at a
transverse angle relative to a surgical instrument, e.g., a cutting
instrument, inserted into to the patient 10 through the umbilicus.
As will be appreciated by a person skilled in the art, the second
additional access hole 26 can be formed in any way through the
patient's abdominal wall 14 to provide access to the patient's
abdominal cavity, but in an exemplary embodiment it is formed using
a trocar 28 in a way similar to that discussed above for the other
percutaneous abdominal opening 12 created using the trocar 16. The
trocars 16, 28 inserted through the percutaneous abdominal openings
12, 26 can include any trocar, same or different from each
other.
As will be appreciated by a person skilled in the art, access holes
in the patient 10 can be formed in any way. Non-limiting
embodiments of a trocar that can be used to form an access hole can
be found in U.S. Patent Publication No. 2007/0260273 filed May 8,
2006 and entitled "Endoscopic Translumenal Surgical Systems," which
is hereby incorporated by reference in its entirety. An exemplary
embodiment of a trocar can include a trocar housing configured to
allow a surgical device to pass therethrough, and a trocar sleeve
or overtube mated to or extending from the trocar housing. The
trocar can also include an obturator configured to pass through the
trocar housing and the trocar sleeve. The obturator can have an
inner lumen formed therethrough for receiving a scoping device
and/or other surgical device therein, and a distal end configured
penetrate through tissue. The trocar sleeve can be slidably
disposed over the obturator and can function as a placeholder after
the trocar is inserted through tissue and the obturator is removed.
Non-limiting embodiments of a sleeve and an obturator that can be
used to form an abdominal access hole can be found in previously
mentioned U.S. patent application Ser. No. 12/242,333 filed Sep.
30, 2008 and entitled "Methods And Devices For Performing
Gastrectomies And Gastroplasties" and U.S. patent application Ser.
No. 12/242,353 filed Sep. 30, 2008 and entitled "Methods And
Devices For Performing Gastrectomies And Gastroplasties."
Once access to the abdominal cavity is obtained, the surgeon can
insufflate the patient's abdominal cavity through an opening in the
patient's abdomen, as will be appreciated by a person skilled in
the art, to expand the abdominal cavity and provide a larger, more
easily navigable surgical workspace. For example, the surgeon can
insufflate the abdominal cavity by passing a fluid under pressure,
e.g., nontoxic carbon dioxide gas, through the trocar 16. The fluid
can have a pressure in the range of about 10 to 15 mm Hg, or any
other pressure, as will be appreciated by a person skilled in the
art. The trocar 16 can include one more seals that prevent the
insufflation fluid from escaping the abdominal cavity through the
trocar 16. A non-limiting example of a sealing trocar that does not
use seals is the SurgiQuest AirSeal.TM. available from SurgiQuest,
Inc. of Orange, Conn. If one or more openings in addition to the
abdominal access hole 12 having the trocar 16 positioned therein
are formed through the patient's abdominal wall 14 and have a
surgical device, e.g., a trocar, extending therethrough, the device
can be configured to provide a seal that prevents the insufflation
fluid from escaping the abdominal cavity therethrough.
As shown in FIG. 4, the surgeon can in addition to or instead of
one or more abdominal access holes form a vaginal opening or access
hole 30 in a vaginal wall of the patient 10 to create an opening
between the vagina and the patient's abdominal cavity to gain
access to the abdominal cavity. The vaginal access hole 30 can be
formed through the vaginal wall in any way, as will be appreciated
by a person skilled in the art. In an exemplary embodiment, a
trocar 34 can be inserted through the vaginal wall to form the
vaginal access hole 30, thereby creating an opening between the
vagina and the patient's abdominal cavity.
As mentioned above, a scoping device can be used in the
gastroplasty, such as an endoscope 32. The endoscope 32 can be
advanced into the vagina before formation of the vaginal access
hole 30, and/or it can be advanced through the trocar 34 in the
vaginal access hole 30 after formation to provide visualization
inside the patient's body during the surgical procedure. The
vaginal access hole 30 can be formed before or after the abdominal
access hole 12 of FIG. 1, but in an exemplary embodiment, the
vaginal access hole 30 is formed after the abdominal access hole 12
to allow prior insufflation of the patient's abdominal cavity
through the abdominal access hole 12. Before forming the vaginal
access hole 30, as will be appreciated by a person skilled in the
art, the patient's vaginal opening can be dilated using a surgical
instrument, e.g., a weighted speculum, and/or one or more sutures.
The vaginal access hole 30 can have any shape and size, but the
vaginal access hole 30 preferably has a diameter of about 18 mm and
is configured to allow passage of a surgical instrument, e.g., a
trocar, a scoping device, a surgical stapler, a clip applier, etc.,
having a diameter in a range of about 5 to 18 mm.
During the surgical procedure, the patient's stomach can be
difficult to adequately access. The patient's liver can be
retracted during the gastroplasty to help the surgeon gain better
access to the patient's stomach. Although the liver can be
retracted at any time during the surgical procedure, in an
exemplary embodiment the liver is retracted after insertion into
the patient 10 of a scoping device to provide visualization of the
abdominal cavity before and during retraction of the liver.
Although visualization before, during, and/or subsequent to liver
retraction can be provided using a scoping device that is
introduced into the abdominal cavity through an opening in the
abdominal wall 14, providing visualization with a vaginally
introduced scoping device can allow for increased abdominal work
space and/or reduce the "chopstick" effect of abdominally
introduced instruments. The liver can be retracted in any way
appreciated by a person skilled in the art, but the liver is
preferably retracted using at least one device inserted into the
abdominal cavity of the patient 10 through, e.g., the
previously-formed abdominal access hole 12, through another
abdominal opening, through a vaginal access hole, etc. Also as will
be appreciated by a person skilled in the art, a draining device,
e.g., a penrose drain, a Jackson-Pratt drain, etc., can be disposed
in the patient's abdominal cavity to help hold the liver and/or
drain excess fluid that can accumulate in the abdominal cavity
during the surgical procedure, particularly following liver
retraction.
In an exemplary embodiment, a retractor device, such as a Nathanson
liver retractor, can be used to retract the patient's liver. FIG. 5
illustrates one embodiment of a liver retraction procedure using a
Nathanson liver retractor 36 to retract a liver 38 of the patient
10 away from a stomach 40 of the patient 10. As will be appreciated
by a person skilled in the art, the surgeon can use the Nathanson
liver retractor 36 to "hook" the liver 38 and hold the liver 38
away from the stomach 40 in a desired retracted position. The
Nathanson liver retractor 36 can be inserted directly inserted
through the abdominal access hole 12 as illustrated, or the
Nathanson liver retractor 36 can be advanced through a cannulated
device providing access into the patient's abdominal cavity, e.g.,
through a vaginally inserted trocar, through a multiple port access
device, through a sleeve, etc. Although not shown in FIG. 5, the
patient's abdominal cavity can be visualized during liver
retraction using a scoping device advanced into the patient 10. A
grasper (not shown) can be advanced through the abdominal wall 14,
e.g., directly, through a multiple port access device 16, through a
trocar, via a working channel of a scoping device, etc., to assist
in retracting the liver 38 and/or otherwise assist in the
gastroplasty.
Optionally, as illustrated in FIG. 5, a support 42 external to the
patient 10 can be used to mount the Nathanson liver retractor 36 to
the examination table 18 on which the patient 10 rests, although
any other support can be used if a support is used at all for a
liver retractor. By mounting the Nathanson liver retractor 36, the
surgeon does not need to continuously hold the Nathanson liver
retractor 36 in place during the surgical procedure, thereby
freeing the surgeon to attend to other surgical matters, and/or
reducing the required number of operating room personnel.
Non-limiting embodiments of a support can be found in previously
mentioned U.S. patent application Ser. No. 12/242,333 filed Sep.
30, 2008 and entitled "Methods And Devices For Performing
Gastrectomies And Gastroplasties" and U.S. patent application Ser.
No. 12/242,353 filed Sep. 30, 2008 and entitled "Methods And
Devices For Performing Gastrectomies And Gastroplasties." The
support can have a variety of sizes, shapes, and configurations,
but as illustrated, the support 42 can include an adapter 44 and a
flexible arm 46 configured to couple to the mounted device and
configured to be coupled at a terminal end thereof to the adapter
44. The flexible arm 46 is generally configured to be movable, as
will be appreciated by a person skilled in the art, to allow the
mounted device's position to be adjusted relative to the
examination table 18. The adapter 44 can be movable and can mate,
as shown, to a table mount coupled to the examination table 18 and
including a table rail 48 and a bracket 50 coupled at its
respective terminal ends to the table rail 48 and the adapter 44.
In an alternate embodiment, in addition to or instead of the
examination table 18, the support can mount to another stable
structure near the patient 10, e.g., a wall, the ceiling, an
independent structure standing on the floor similar to an IV pole
or a microphone stand, an overhead fixture, etc. The Nathanson
liver retractor 36 can be mounted at any time during the
gastroplasty procedure, and its mounting can be re-adjusted and/or
released at any time, but in an exemplary embodiment, the Nathanson
liver retractor 36 is mounted before arranging the liver 38 into a
desired retracted location in the patient 10. The Nathanson liver
retractor 36 and/or the support 42, e.g., the flexible arm 46, the
adapter 44, and/or the bracket 50, can be adjusted to help move the
liver 38 to its desired retracted location.
A person skilled in the art will appreciate that a support can be
used to mount the Nathanson liver retractor 36 and/or any other
surgical instrument used during the gastroplasty that does not
require constant hands-on manipulation. Multiple supports can be
used in a single surgical procedure.
Various other non-limiting examples of liver retractor devices and
liver retraction methods, such as using a tacker device to apply
one or more tacks to the liver and retracting the liver using a
device inserted through a multiple port access device, can be found
in previously mentioned U.S. patent application Ser. No. 12/242,333
filed Sep. 30, 2008 and entitled "Methods And Devices For
Performing Gastrectomies And Gastroplasties," U.S. patent
application Ser. No. 12/242,353 filed Sep. 30, 2008 and entitled
"Methods And Devices For Performing Gastrectomies And
Gastroplasties," and U.S. patent application Ser. No. 12/242,381
filed Sep. 30, 2008 and entitled "Methods And Devices For
Performing Gastroplasties Using A Multiple Port Access Device."
Prior to transecting the stomach 40, the stomach 40 can be
separated from tissue attached to the stomach 40, e.g., an omentum,
vessels, any adhesions on the stomach 40, etc., to free a fundus of
the stomach 40. As will be appreciated by a person skilled in the
art, the tissue attached to the stomach 40 can be separated from
the stomach 40 using any one or more dissecting devices. A person
skilled in the art will also appreciate that the term "dissector,"
"dissecting device," or "dissecting surgical instrument" as used
herein is intended to encompass any surgical instrument that is
configured to cut tissue, e.g., a scalpel, a harmonic scalpel, a
blunt dissector, a cautery tool configured to cut tissue, scissors,
an endoscopic linear cutter, a surgical stapler, etc. The desired
tissue can be separated from the stomach 40 in any way, but in an
exemplary embodiment the surgeon cuts adjacent to the greater
curvature of the stomach 40 to free the fundus from the omentum.
The dissector can be introduced into the patient 40 through any
access hole (natural or surgically created). In one embodiment
shown in FIG. 6, a dissector 52 can be inserted through the trocar
16 in the abdominal access hole 12 and used to cut an omentum 54
from the stomach 40. As shown in this illustrated embodiment, the
dissector 52 has an end effector 52a with a distal end having a
pair of movable jaws configured to cut tissue. With the desired
tissue dissected, a posterior of the stomach 40 can be visualized
and/or accessed between an antrum 40a of the stomach 40 and an
angle of His 40b of the stomach 40.
In an exemplary embodiment, the omentum 54 and/or any other desired
tissue can be tensioned using a grasper 56 while the dissector 52
dissects tissue from the stomach 40. The grasper 56 can be
introduced into the patient 10 in any way, e.g., through a multiple
port access device, through a trocar in a percutaneous abdominal
opening, through a vaginal access hole, etc. Generally, the surgeon
can pass tissue from the dissector 52 to the grasper 56, grasp the
tissue with the grasper 56, pull the grasper 56 to tension the
grasped tissue, and dissect tissue using the dissector 52. The
surgeon can repeat this process any number of times to free the
stomach fundus. Although only one grasper is shown in the
embodiment illustrated in FIG. 6, the surgeon can use any number of
graspers, which can be inserted in any way into the patient's
abdominal cavity. If a scoping device is inserted into the
patient's abdominal cavity, the surgeon can use the scoping device
to provide visualization to, e.g., help position the grasper 56
and/or an additional grasper. Alternatively or in addition, a
scoping device can visualize the posterior of the stomach 40 during
and/or after dissection of desired tissue.
FIG. 7 illustrates an embodiment using multiple graspers where a
second abdominal access hole 58, e.g., a percutaneous opening, can
be formed using a second trocar 60 similar to that described above
regarding the abdominal access holes 12, 26 formed using the
trocars 16, 28. The surgeon can insert any one or more desired
surgical instruments simultaneously and/or sequentially through the
second abdominal access hole 58, with or without the second trocar
60 disposed therein. For non-limiting example only, the surgeon can
advance at least one additional grasper through the second
abdominal access hole 58 and use the second grasper in cooperation
with a grasper 62 inserted through a vaginal trocar 64 to tension
the omentum. In some embodiments, the surgeon can use only a
grasper inserted through the abdominal wall 14, e.g., through the
second abdominal access hole 58, and not a vaginally inserted
grasper. Alternatively, the surgeon can advance the additional
grasper through another access hole, e.g., the vaginal access hole
via a working channel of an endoscope 66, through a multiple port
access device inserted in an abdominal or vaginal access hole, etc.
In some embodiments, one or more graspers for tensioning the
dissected tissue can be inserted through the vaginal access hole,
e.g., through a multiple port access device, and none through the
patient's abdomen.
As illustrated in another embodiment in FIG. 8, using a multiple
port access device 68 positioned in the patient's abdomen, a
dissector 73 can be advanced into the patient 10 and used to
dissect the omentum 54. A grasper 70 can be transorally advanced
into the stomach 40 through a scoping device 72, advanced through a
digestive tract opening 74, and advanced into the abdominal cavity
of the patient 10 to grab and tension the omentum 54. The digestive
tract opening 74 can be formed in any way appreciated by a person
skilled in the art. The digestive tract opening 74 can be formed at
any location on the stomach 40, but it is preferably formed in a
portion of the stomach 40 that will form part of the stomach sleeve
following transection to help maintain constant positioning of any
device(s) inserted through the digestive tract opening 74 before,
during, and/or after transection. The digestive tract opening 74 is
shown formed in the stomach wall, but the digestive tract opening
74 can be formed anywhere in the patient's digestive tract, e.g.,
in the stomach wall, in an intestine wall, etc. The digestive tract
opening 74 can have any shape and size. If the digestive tract
opening 74 is not included in a portion of the stomach fundus
detached from a remainder of the stomach 40 during transection, the
digestive tract opening 74 can be closed in any way appreciated by
a person skilled in the art, e.g., using a surgical stapler
inserted through an abdominally inserted multiple port access
device.
FIG. 9 shows an alternate embodiment using a multiple port access
device 76 positioned substantially at an umbilicus of the patient
10 for dissecting tissue attached to the stomach 40. In this
illustrated embodiment, the surgeon can use a scoping device
advanced through a first one of the multiple port access device's
ports 78a, 78b, 78c to visualize the surgical site, a dissector
advanced through a second one of the ports 78a, 78b, 78c to dissect
the tissue attached to the stomach 40, and a grasper advanced
through a third one of the ports 78a, 78b, 78c to tension the
tissue being dissected. Alternatively or in addition, a grasper
advanced through a trocar 80 inserted through a percutaneous
vaginal access hole 82 and/or a grasper advanced through a trocar
84 inserted through a percutaneous abdominal access hole 86 can be
used to tension the tissue being dissected. A grasper inserted
through at least the percutaneous abdominal access hole 86 can
allow tissue to be tensioned in the patient 10 at a transverse
angle relative to a surgical instrument, e.g., a cutting
instrument, inserted into to the patient 10 through the multiple
port access device 76 at the umbilicus.
In some embodiments, an illustrated in one embodiment in FIG. 10, a
dissector can be used to form an opening 88 under the stomach 40.
The opening 88 can have any size, shape, and configuration, but in
the illustrated exemplary embodiment, the opening 88 can include a
tunnel having a substantially constant diameter along its
longitudinal length and having a substantially circular
cross-sectional shape. The surgeon can visualize the posterior of
the stomach 40 from the antrum 40a to the angle of His 40b by,
e.g., advancing a scoping device through at least a partial
longitudinal length of the opening 88. Any dissector can be used to
form the opening 88, such as an exemplary dissector described in
previously mentioned U.S. patent application Ser. No. 12/242,381
filed Sep. 30, 2008 and entitled "Methods And Devices For
Performing Gastroplasties Using A Multiple Port Access Device."
Once tissue attached to the stomach 40 is dissected from the
omentum 54 as desired and the opening 88 under the stomach 40 has
optionally been formed, the stomach 40 can be transected. As will
be appreciated by a person skilled in the art, the stomach 40 can
be transected using any one or more transecting devices. A person
skilled in the art will also appreciate that the term "transactor,"
"transecting device," or "transecting surgical instrument" as used
herein is intended to encompass surgical devices that alone or in
combination can cut and secure tissue, e.g., a surgical stapler
configured to cut and staple tissue. Non-limiting embodiments of
surgical staplers can be found in U.S. Pat. No. 5,285,945 issued
Feb. 14, 1995 and entitled "Surgical Anastomosis Stapling
Instrument," U.S. Pat. No. 6,905,057 issued Jun. 14, 2005 and
entitled "Surgical Stapling Instrument Incorporating A Firing
Mechanism Having A Linked Rack Transmission," U.S. Pat. No.
7,111,769 issued Sep. 26, 2006 and entitled "Surgical Instrument
Incorporating An Articulation Mechanism Having Rotation About The
Longitudinal Axis," U.S. Pat. No. 6,786,382 issued Sep. 7, 2004 and
entitled "Surgical Stapling Instrument Incorporating An
Articulation Joint For A Firing Bar Track," U.S. Pat. No. 6,981,628
issued Jan. 3, 2006 and entitled "Surgical Instrument With A
Lateral-Moving Articulation Control," U.S. Pat. No. 7,055,731
issued Jun. 6, 2006 and entitled "Surgical Stapling Instrument
Incorporating A Tapered Firing Bar For Increased Flexibility Around
The Articulation Joint," U.S. Pat. No. 6,964,363 issued Nov. 15,
2005 and entitled "Surgical Stapling Instrument Having Articulation
Joint Support Plates For Supporting A Firing Bar," U.S. Pat. No.
6,959,852 issued Nov. 1, 2005 and entitled "Surgical Stapling
Instrument With Multistroke Firing Incorporating An Anti-Backup
Mechanism," U.S. Pat. No. 7,434,715 issued Oct. 14, 2008 and
entitled "Surgical Stapling Instrument Having Multistroke Firing
With Opening Lockout," U.S. Pat. No. 7,000,819 issued Feb. 21, 2006
entitled "Surgical Stapling Instrument Having Multistroke Firing
Incorporating A Traction-Biased Ratcheting Mechanism," and U.S.
Pat. No. 7,364,061 issued Apr. 29, 2008 and entitled "Surgical
Stapling Instrument Incorporating A Multistroke Firing Position
Indicator And Retraction Mechanism," which are hereby incorporated
by reference in their entireties.
The transactor can have any size and shape, but in an exemplary
embodiment if the transactor is vaginally advanced into the patient
10, the transector preferably has a relatively long longitudinal
length, e.g., at least about 4 feet, and has at least one flexible
joint. Non-limiting embodiments of a transactor having at least one
flexible joint can be found in previously mentioned U.S. patent
application Ser. No. 12/242,381 filed Sep. 30, 2008 and entitled
"Methods And Devices For Performing Gastroplasties Using A Multiple
Port Access Device." A person skilled in the art will also
appreciate that the transector can be inserted into the patient 10
through any opening, e.g., through an abdominal access hole, a
vaginal access hole, a natural orifice, etc., with or without a
trocar or multiple port access device positioned therein. Further,
at least one grasper inserted through any opening(s) in the patient
10 can be used to tension the stomach 40 while it is being
transected and/or to hold a sizer in a desired location along the
stomach's lesser curvature.
In an exemplary embodiment, the transactor can be configured to cut
tissue and to deliver one or more fasteners to tissue. In
particular, the transector can have at its distal end an end
effector configured to engage tissue. The end effector can have a
cut-free region such that the transector can cut tissue engaged in
a first portion, e.g., distal portion, of the end effector without
cutting tissue engaged in a second portion, e.g., proximal portion,
of the end effector. The end effector can also have a fastener-free
region, which can be substantially at the same location as the
cut-free region, such that the device can fasten tissue engaged in
the distal portion of the end effector without fastening tissue in
the end effector's proximal portion. A device having a proximal
cut-free region, and/or a proximal fastener-free region
substantially at the same location as the proximal cut-free region,
can be particularly effective in a Magenstrasse and Mill procedure
where only a portion of the stomach 40 is cut to form a stomach
sleeve. Such a device can be used to at least begin a transection
with the device engaging the stomach 40 at a portion of its
perimeter and transecting at least a portion of the stomach 40 a
distance from the stomach's antrum 40a without cutting through the
engaged portion of the stomach's perimeter. Exemplary transectors
will be discussed in more detail below.
At any time prior to transecting the stomach 40, the surgeon can
manipulate the stomach 40 to form a gastric tube or stomach sleeve
in the stomach 40. In an exemplary embodiment, the stomach sleeve
can be formed after creation of the tunnel 88 under the stomach 40
and an opening created through anterior and posterior walls of the
stomach 40, as discussed further below, although the sleeve can be
formed before or after creation of the tunnel 88 or the opening. As
illustrated in FIG. 11, the surgeon can introduce a sizing device
106 into the stomach 40 to help size the portion of the stomach 40
that will form the stomach sleeve. The sizing device 106 can be
introduced into the stomach 40 in any way, but in this illustrated
exemplary embodiment, the sizing device 106 is transorally
introduced into the stomach 40, e.g., through a mouth 108 and an
esophagus 110 of the patient 10. A person skilled in the art will
appreciate that the term "sizer," "sizing device," or "sizing
instrument" as used herein is intended to encompass any surgical
instrument, e.g., a bougie, a scoping device, a catheter, etc, that
is configured to indicate a desired gastric sleeve area. The sizer
106 can optionally include a light at its distal end to help the
surgeon advance the sizer 106 through the esophagus 110 and
desirably position the sizer 106 in the stomach 40. The sizer's
size and shape can generally correspond to a size and shape of the
stomach sleeve desired to be formed in the patient 10, so the
surgeon can choose a sizer having any size, shape, and
configuration that generally corresponds to the desired sleeve
dimensions. In an exemplary embodiment, the sizer 106 is a flexible
surgical instrument having a substantially cylindrical shape and a
substantially constant diameter along the sizer's longitudinal
length in the range of about 28 to 42 French (about 9.3 to 14
mm).
The sizer 106 can be adjusted in the stomach 40 to place the sizer
106 in a sizing position that generally indicates the size and
position of the stomach sleeve following at least partial
transection of the stomach 40. In an exemplary embodiment, the
sizer 106 in the sizing position extends along a lesser curvature
40c of the stomach 40 and into a pylorus 93 of the stomach 40 so at
least a distal-most end 106a of the sizer 106 extends to the
pyloric sphincter or valve of the pylorus 93. The sizer 106 can be
adjusted in the patient 10 in any way, as will be appreciated by a
person skilled in the art. In an exemplary embodiment, the sizer
106 can be adjusted in the stomach 40 using a flexible and/or rigid
grasper inserted into the stomach 40 through an abdominal access
hole. The grasper can include an end effector having two opposed,
movable jaws configured to grasp and move the sizer 106 once the
sizer 106 has been adequately advanced into the patient 10 for the
grasper to access it. A scoping device inserted into the stomach 40
can have a light located thereon which can help the surgeon find
and grasp the sizer 106 with the grasper and to locate the pyloric
valve. As mentioned above, if the sizer 106 is advanced into the
stomach 40 before the opening is created, the sizer's positioning
along the lesser curvature 40c can assist in the opening's
creation.
As mentioned above, a transector can be introduced into the patient
10 in any way, such as by advancing a transactor 98 having an end
effector 98a in the form of opposed jaws through a trocar 100
inserted in a vaginal access hole 102, as shown in one embodiment
in FIG. 12. In another embodiment illustrated in FIG. 13, the
surgeon can transect the stomach 40 using the transecting device 98
advanced through a multiple port access device 104 positioned in
the patient's umbilicus. The transection can be visualized using at
least one scoping device inserted through any opening, as discussed
herein. For non-limiting example only, visualization of the stomach
40 above and/or underneath the stomach 40 can be performed using,
e.g., a scoping device inserted through the trocar 16 in the
abdominal access hole 12 of FIG. 1, to determine if a desired path
of transection is clear or readily cleared of tissue and/or other
debris. For another non-limiting example, one scoping device can be
used for visualization before the transection, e.g., a scoping
device inserted through the trocar 16 in the abdominal access hole
12 of FIG. 1, and another scoping device during and after the
transection, e.g., a vaginally introduced scoping device. The
stomach 40 can optionally be tensioned during transection. For
example, a suture can be passed through a percutaneous opening,
e.g., through a trocar or other port, and the suture can be
inserted through the fundus of the stomach 40 and back out the
stomach 40 and out the percutaneous port. The free ends of the
suture can thus be tensioned to lift and stretch the stomach 40,
thereby facilitating transection. The surgeon can also place one or
more draining devices in the stomach fundus following the
transection, e.g., along a greater curvature of the stomach sleeve
formed by the transection. If used, the sizer can be removed from
the stomach 40 at any time during the surgical procedure, but in an
exemplary embodiment the sizer is removed from the patient 10 by
retracting it through the patient's mouth, if the sizer was
transorally introduced, after the stomach 40 has been transected
and inspected via scoping device visualization for any uncorrected
and potentially dangerous irregularities, e.g., improperly bent
staples, improperly placed staples, untied sutures, etc.
However advanced to the stomach 40, in an exemplary embodiment
shown in FIG. 14, a transector 90, e.g., a linear surgical stapler
having an end effector 92 at a distal end thereof, can be used to
engage a portion of the stomach 40 and at least begin transection
of the stomach 40 by cutting and/or fastening a portion of the
tissue engaged by the end effector 92. The end effector 92 can be
initially positioned at any location with respect to the stomach 40
before the transector 90 transects the stomach 40, but in an
exemplary embodiment, the transactor 90 can be positioned in an
initial position with a proximal end 92a of the end effector 92
located substantially at the antrum 40a of the stomach 40 and with
a distal end 92b of the end effector 92 located a distance d from
the antrum 40a toward the angle of His 40b. Thus, in the initial
position the end effector 92 can engage a folded edge of the
stomach 40 at the antrum 40a. If an opening or tunnel has been
formed under the stomach 40, e.g., the opening 88 of FIG. 10, the
opening can help provide guidance for positioning the end effector
92 in its initial position. In some embodiments, as discussed
further below, the end effector 92 can have a longitudinal length
such that the distal end 92b of the end effector 92 extends beyond
the angle of His 40b when its proximal end 92a is positioned
substantially at the antrum 40a such that the transector 90 can
form a stomach sleeve without being substantially repositioned from
its initial position.
As mentioned above, the surgeon can use a surgical instrument such
as a scoping device to visualize the posterior and/or other area of
the stomach 40. Such visualization can help determine the initial
position of the transecting device 90 relative to the stomach 40.
Initial positioning of the transector 90 can be determined in any
way, as will be appreciated by a person skilled in the art. For
example, a distance can be measured along a greater curvature 91 of
the stomach 40 from the pylorus 93 of the stomach 40, and in an
exemplary embodiment from a pyloric sphincter or valve of the
pylorus 93, to determine an initial position for the distal end 92b
of the end effector 92. In an exemplary embodiment, the initial
position for the distal end 92b of the end effector 92 has a
lateral distance from the pylorus 93 in a range of about 2 to 6
centimeters (cm) and has an axial distance from the antrum 40a of
about 2 cm. The size of the end effector 92 can generally determine
its initial position, particularly if a sizer is used to provide a
guide for positioning of the stomach sleeve to be formed. The end
effector 92 can simply be positioned to engage the antrum 40a with
its distal end 92b positioned along the stomach 40 toward the angle
of His 40b. Alternatively or in addition, the initial position for
the distal end 92b of the end effector 92 can be marked in any way,
such as by mentally marking or remembering the initial position for
the end effector's distal end 92b or by applying a marker. As will
be appreciated by a person skilled in the art, any marker can be
used to mark the initial position for end effector's distal end
92b, e.g., a mark using electrocautery, a mark using a harmonic
scalpel, an ink marker applied in any way appreciated by a person
skilled in the art, such as via a marking device inserted through
an abdominal or other access hole, etc.
With the transactor 90 engaging the stomach 40, the transecting
device 90 can be actuated in any way appreciated by a person
skilled in the art to cut the stomach 40 and to create a hole or
opening 94 through anterior and posterior walls of the stomach 40,
as shown in FIG. 15. The opening 94 can have a terminal end 94a
approximately the distance d from the antrum 40a toward the angle
of His 40b, e.g., substantially where the end effector's distal end
92b was positioned to form the opening 94. The opening 94 can more
easily allow a transection device, either the transector 90 or one
or more other transectors, to be desirably positioned with respect
to the stomach 40 to transect the remainder of the stomach 40
between the opening 94 and the angle of His 40b, as discussed
further below. The opening 94 can have any size and shape, e.g.,
substantially circular, etc. Generally, a longitudinal length
d.sub.d of the opening 94 can correspond to a longitudinal length
of the distal cutting region of the transector's end effector 92,
while an uncut longitudinal length d.sub.p of the stomach 40
extending between a perimeter or folded edge of the stomach 40 at
the antrum 40a and the opening 94 can correspond to a longitudinal
length of the proximal cut-free region of the transector's end
effector 92. The opening 94 can be closed or sealed to help prevent
bleeding and/or prevent fluid or debris seepage between the stomach
40 and the patient's abdominal cavity. Having a closed opening can
also provide the surgeon with increased flexibility during the
surgical procedure because the surgeon can create the opening 94
without immediately transecting the stomach 40 thereafter but
instead first, e.g., size the stomach 40. The opening 94 can be
closed in any way, as will be appreciated by a person skilled in
the art, such as by applying one or more fasteners or securing
elements, e.g., staples 96 as shown applied by the transector 90,
sutures, glues such fibron glues, pledgets, etc. The securing
element(s) can be applied following creation of the opening 94,
and/or the transactor 90 can be configured to apply one or more
securing elements when it forms the opening 94, e.g., by applying
the staples 96 from a distal portion of the end effector 92 but not
from a proximal portion of the end effector 92.
A transector having a cut-free region and/or a fastener-free region
can have a variety of configurations. FIG. 16 illustrates one
embodiment of a staple cartridge 112 having a proximal cut-free and
fastener-free region. The staple cartridge 112 is configured to be
removably and replaceably disposed in one of two movable jaws of an
end effector of a transector. A person skilled in the art will
appreciate that while the transactor in this illustrated embodiment
is configured to apply surgical staples, a transector can be
configured to apply any type of fastener to secure tissue. A person
skilled in the art will also appreciate that although FIG. 16
illustrates a removable cartridge 112 that can be loaded into any
transection device, e.g., the transactor 98 of FIGS. 12 and 13,
need not include a cartridge but rather be a single-use device
having the fasteners disposed directly therein. In other
embodiments, various portions of the transector can be removable
and replaceable, such as the entire end effector or the cutting
element.
As shown in FIG. 16, the staple cartridge 112 can have a
substantially planar tissue-contacting surface 114 on one side
thereof. As will be appreciated by a person skilled in the art,
when the cartridge 112 is disposed in an end effector of a
transection device and tissue is engaged by opposed jaws of the end
effector, tissue can be pressed against the tissue-contacting
surface 114 between proximal and distal ends 116, 118 of the
tissue-contacting surface 114. The cartridge 112 can be configured
so that tissue engaged adjacent the tissue-contacting surface 114
in a distal region 120 of the cartridge 112 and adjacent a
tissue-contacting surface of a jaw opposed to the jaw containing
the cartridge 112, e.g., an anvil, can be cut and stapled without
cutting and stapling tissue engaged adjacent the tissue-contacting
surface 114 in a proximal region 122 of the cartridge 112. The
distal and proximal regions 120, 122 can each extend along any
portion of the longitudinal length of the cartridge 112, but in an
exemplary embodiment, the proximal region 122 has a longitudinal
length Lp at least as long as a longitudinal length Ld of the
distal region 120, e.g., has a longitudinal length Lp in a range of
about 10% to 70% of a total length (Lp+Ld) between the proximal and
distal ends 116, 118, e.g., at least about 20%. The total length
between the proximal and distal ends 116, 118 can vary, but in an
exemplary embodiment, the total length is in a range of about
60-180 mm, with the proximal region 122 having a length Lp in a
range of about 30-90 mm.
The cartridge's distal region 120 can generally be configured to
cut and staple tissue in any way appreciated by a person skilled in
the art. The proximal region 122 can also have a variety of
configurations to prevent tissue engaged adjacent thereto from
being cut or stapled. To help fasten tissue, the distal region 120
can include a plurality of staple holes 124 in which staples can be
loaded for deployment into tissue. The proximal region 122 can, as
shown, not include such staple holes and instead can have a
substantially continuous solid surface along the tissue-contacting
surface 114. In this way, if a staple driver longitudinally
translates through the cartridge 112 to eject staples therefrom,
staples can be driven into tissue in the distal region 120 while no
staples will be driven from the proximal region 122. Indeed,
staples need not be loaded into the proximal region 122 at all. In
other embodiments, the proximal region 122 can have holed but
staples can only be loaded in the distal region 120 and not in the
proximal region 122 to form a proximal staple-free region.
To help cut tissue, the cartridge 112 can include a longitudinal
slot 126 extending at least through the distal region 120, or
through both the distal and proximal regions 120, 122 as shown in
this illustrated embodiment. A cutting element, e.g., a knife
having a sharp cutting edge, can translate along the longitudinal
slot 126 to cut tissue engaged adjacent the distal region 120
without cutting tissue adjacent the proximal region 122, as
discussed further below. Generally, the cutting element can
translate along a full or partial length of the cartridge 112
between the proximal and distal ends 116, 118 in the distal and/or
proximal regions 120, 122. If the cutting element moves along only
a partial length of the longitudinal length between the proximal
and distal ends 116, 118, the partial length can include the length
of the distal region 120 to allow the cutting element to cut tissue
in the distal region 120. A person skilled in the art will
appreciate that the knife can have a variety of sizes, shapes, and
configurations and that its sharp cutting edge can extend along any
portion of the knife's perimeter. A person skilled in the art will
also appreciate that the cutting element can also translate through
a corresponding longitudinal slot in a jaw opposed to the cartridge
112, e.g., a slot in an anvil.
FIGS. 17-22 partially illustrate a second embodiment of a
transector having a proximal cut-free and fastener-free region
where tissue engaged adjacent the proximal region is not cut or
fastened. In this illustrated embodiment, a transector component
that can be partially or fully removably and/or fixedly attached to
any transection device includes a staple cartridge 128 and a
cutting assembly 130. As will be appreciated by a person skilled in
the art, the staple cartridge 128 and the cutting assembly 130 can
each have a variety of configurations and can each include more or
fewer elements than those shown. The cartridge 128 is similar to
the cartridge 112 of FIG. 16 and has a tissue-contacting surface
132, a distal cutting/fastening region 134, a proximal
cut-free/fastener-free region 136, and a longitudinal slot 138
extending between distal and proximal ends 140, 142 of the
tissue-contacting surface 132 through which at least a portion of
the cutting assembly 130 can at least partially translate.
Generally, staples can be disposed in staple holes 144 formed in
the cartridge's tissue-contacting surface 132 and ejected into
tissue engaged adjacent the distal region 134. The cartridge 128
includes six longitudinal rows of staple holes 144, three on either
side of the slot 138, although the staple holes 144 can be in any
number and can be arranged in any way.
The cutting assembly 130 includes a pusher bar 146 and a cutting
element, e.g. a knife 148, pivotably attached to a distal end of
the pusher bar 146 with, e.g., a pin 150 shown in FIG. 21. A person
skilled in the art will appreciate that the knife 148 can connect
to the pusher bar 146 with any other connecting element configured
to allow the knife 148 to rotate relative to the pusher bar 146,
e.g., pin-welding, brazening, soldering, an integrated tab or
semi-perforations from material used to form the knife 148, etc.
The knife 148 can, as shown, have a distal cutting edge 148a and a
proximal cut-out 148b on a side of the knife 148 opposite to the
cutting edge 148a. With a distal cutting edge 148a, the knife 148
can cut tissue when the knife 148 moves distally, as discussed
further below. The pusher bar 146 can be attached to an actuation
mechanism (not shown), e.g., a handle assembly, at a proximal
portion 146a of the pusher bar 146, where the actuation mechanism
can be configured to move the cutting assembly 130 relative to the
cartridge 128. A person skilled in the art will appreciate that the
knife and the fasteners can be actuated in any way using any handle
and/or other actuation mechanism. The knife 148 can rotate about
the pin 150 relative to the pusher bar 146 and to the cartridge 128
coupled to the cutting assembly 130, as discussed further below. In
this way, when the knife 148 moves through the cartridge 128, the
knife 148 can move between a first position configured to not cut
tissue in the proximal region 136 and a second position configured
to cut tissue in the distal region 134. A person skilled in the art
will appreciate that the pin 150 and at least a distal portion of
the pusher bar 146 can each also move through the cartridge
128.
The knife 148 is shown in FIGS. 17-20 and 22 attached to the pusher
bar 146 in a cutting position where the knife 148 is in a position
configured to cut tissue engaged by the transactor. Accordingly,
the knife 148 can be in the cutting position in the distal region
134. In the cutting position, at least a portion of the knife 148
including at least a portion of the cutting edge 148a can extend
outside the longitudinal slot 138 and above the tissue-contacting
surface 132. A person skilled in the art will appreciate that
"above" is a relative position indicating that the knife 148
extends through the cartridge's tissue-contacting surface 132
toward an opposed tissue-contacting surface (not shown) against
which tissue can be engaged such that tissue can be clamped between
the two tissue-contacting surfaces. The opposed tissue-contacting
surface, such as that of an anvil, can have any configuration as
will be appreciated by a person skilled in the art.
In a third embodiment of a transector having a proximal cut-free
and fastener-free region illustrated in FIGS. 23-28, a staple
cartridge 154 has a longitudinal slot 156 extending through the
cartridge 154 but extending through a tissue-contacting surface 158
of the cartridge 154 along only a partial longitudinal length
thereof in the cartridge's distal cutting/fastening region 162. The
cartridge 154 is otherwise similar to the staple cartridges
discussed above with the distal cutting/fastening region 162 and a
proximal cut-free/fastener-free region 164. At least a portion of a
cutting assembly 160 can at least partially extend through the slot
156 as the cutting assembly 160 moves through the cartridge 154. By
having a slot 156 in the distal region 162 but not in the proximal
region 164, the cutting assembly 160 cannot extend through the slot
156 to cut tissue except in a distal region 162. Because the
tissue-contacting surface 158 in the proximal region 164 can be a
continuous solid surface without having any openings formed
therein, the cutting assembly 160 cannot access tissue in the
proximal region 164 of the tissue-contacting surface 158, thereby
helping to ensure that tissue in the proximal region 164 is not
cut.
The cutting assembly 160 of FIGS. 26-28 is similar to the cutting
assembly 130 of FIGS. 17-22 discussed above and has a pusher bar
166 and a cutting element, e.g., a knife 168 having a distal
cutting edge 168a and a cut-out 168b, attached to the pusher bar
166 with a pin 170. The distal cutting edge 168a extends along an
entire length of the knife's distal side, although the cutting edge
can, in some embodiments, extend along a partial length of the
knife's side. The knife 168 is illustrated in FIGS. 27 and 28 a
non-cutting position where the knife 168 is configured to not cut
tissue adjacent the tissue-contacting surface 158. Accordingly, the
knife 168 can be in the non-cutting position in the proximal region
164. In the non-cutting position, the cutting edge 168a of the
knife 168 can be contained within the cartridge 154 when the knife
168 translates through at least a portion thereof such that the
cutting edge 168a does not extend "above" the tissue-contacting
surface 158. The position of the knife 168 in the non-cutting
position relative to the pusher bar 166 can position the knife's
cut-out 168b at a distal end of the cutting assembly 160, as shown
in FIGS. 27 and 28. In this way, as discussed further below, a cam
member can engage the cut-out 168b when the cutting assembly 160
moves distally, thereby camming or moving the knife 168 from the
non-cutting position to a cutting position. The pusher bar 166 at
its distal end can have a width w.sub.bar no greater than a width
w.sub.knife of the knife 168 to help prevent the pusher bar 166
from interfering with the cam member's engagement of the knife's
cut-cut 168b. The cut-out 168b can have any size and shape, such as
a having a c-shape as illustrated in this embodiment.
As mentioned above, the cutting element in a transection device can
have a variety of configurations, and it can be configured to move
between different positions as it translates through the
transection device's end effector. In some embodiments, the cutting
element can move distally through the transactor to cut tissue,
while in other embodiments the cutting element can move proximally
through the transactor to cut tissue. Generally, if the cutting
element moves distally through the transactor to cut tissue, the
cutting element has a distal cutting edge and is disposed in the
transector in an initial position adjacent or proximal to the
distal, cutting region of the transector's end effector to allow
the cutting element to cut all tissue engaged in the distal region.
Similarly, if the cutting element moves proximally through the
transactor to cut tissue, the cutting element has a proximal
cutting edge and is disposed in the transactor in an initial
position adjacent or distal to the distal, cutting region of the
transector's end effector to allow the cutting element to cut all
tissue engaged in the distal region.
One embodiment of a transector having a cutting element that moves
distally to cut is illustrated in FIGS. 29-32. The cutting assembly
of FIGS. 23-28 is shown in FIGS. 29-32 moving through the staple
cartridge 154. The cutting assembly can move through at least a
partial length of the slot 156 in the cartridge 154 with the knife
168 in an initial, non-cutting position, shown in FIG. 29, where
the knife 172 is configured to be fully contained within the
cartridge 154 to help prevent the knife 168 from cutting tissue
adjacent the cartridge 154. The knife 168 can be configured to be
in the initial position in the proximal, cut-free region 164 of the
cartridge 154 and to move to a second, cutting position in the
distal, cutting region 162 of the cartridge 154. In an exemplary
embodiment, the knife 168 can be configured to move through an
entire length of the proximal region 164 in the initial,
non-cutting position and through an entire length of the distal
region 162 in the cutting position.
The knife 168 can move between the non-cutting and cutting
positions in a variety of ways, but as shown in this illustrated
embodiment, a bottom surface of the cartridge's longitudinal slot
156 can include a surface feature, e.g., a cam member 157, to help
move the knife 168 between its non-cutting and cutting positions.
The cam member 157 can be integrally formed with the cartridge 154,
although in other embodiments the cam member 157 can be an
independent element fixedly or removably coupled to the cartridge
154 or to the jaw of the transector. The cam member 157 can have
any size and shape. As shown in this illustrated embodiment, the
cam member 157 has a size and shape corresponding to a size and
shape of the cut-out 168b in the knife 168, e.g., c-shaped. In this
way, the cut-out 168b can receive the cam member 157 therein when
the cut-out 168b reaches the cam member 157 in the knife's
translation through the slot 156, as shown in FIG. 29, and can use
the cam member 157 as leverage to rotate the knife 168 around the
pin 170 in a counter-clockwise direction as the cutting assembly
moves distally, as shown in FIG. 30. Because the pin 170 that
attaches the knife 168 to the pusher bar 166 can be positioned such
that the knife's pivot point at the pin 170 is located "above" the
cam member 157 with the knife 168 in the initial position, the
knife 168 can have adequate leverage to rotate around the pin 170
relative to the pusher bar 166 as the knife 168 continues its
distal movement past the cam member 157. As the knife 168 rotates
around the pin 170 with the cam member 157 received in the knife's
cut-out 168b, the knife's cutting edge 168a can move from its
containment within the cartridge 154 to extend at least partially
outside the cartridge 154 through the opening of the slot 156 in
the distal region 162.
The knife 168 can cut tissue adjacent the tissue-contacting surface
158 when it is rotated from the non-cutting position to the cutting
position, as shown in FIG. 31, with the cutting edge 168a of the
knife 168 extending through the longitudinal slot 156 above the
tissue-contacting surface 158. The knife 168 in the cutting
position can be rotated any amount from the non-cutting position,
but as illustrated in this exemplary embodiment, the knife 168 can
rotate about 90.degree. from the non-cutting position to the
cutting position. Accordingly, the knife 168 in the cutting
position in the cartridge's distal region 162 can be configured to
cut tissue adjacent the tissue-contacting surface 158 using the
knife's cutting edge 168a facing distally. A person skilled in the
art will appreciate that the knife 168 can begin to cut tissue as
the knife 168 transitions between the non-cutting and cutting
positions before the knife 168 has fully moved about 90.degree. to
the cutting position. Tissue engaged by the transector can provide
adequate tension to hold the knife 168 in the cutting position
during distal translation of the knife 168.
The cutting assembly can be configured to move distally in the
cartridge 154 beyond the cam member 157 with the knife 168 in the
cutting position until a stop member prevents further distal
movement of the cutting assembly. The stop member can have a
variety of configurations as will be appreciated by a person
skilled in the art. As shown in this illustrated embodiment, a
distal edge 156a of the slot 156 forms the stop member. When a
distal-most end of the cutting assembly, e.g., the knife's cutting
edge 168a, contacts the slot's distal edge 156a, the distal edge
156a can halt the cutting assembly's distal movement, as shown in
FIG. 32.
A second embodiment of a transector having a cutting element that
moves distally is illustrated in FIGS. 33-36. The cutting assembly
includes a knife 172 attached to a pusher bar 178 with a pin 180.
The cutting assembly can be configured to move through a
longitudinal slot 182 formed in a staple cartridge 184 and, at
least when the knife 172 is in a cutting position, the knife 172
can be configured to move through a corresponding longitudinal slot
(not shown) formed in an anvil 186. The cartridge 184 and the anvil
186 form an end effector of the transactor, with the cartridge 184
and the anvil 186 being located on opposed jaws configured to clamp
tissue therebetween in a tissue gap 176, as will be appreciated by
a person skilled in the art. The knife 172 has a distal cutting
edge 174.
In an initial, non-cutting position shown in FIG. 33, the knife 172
is configured to be fully retained within and to distally translate
through the cartridge 184 in an initial position without cutting
tissue engaged between the anvil 186 and the cartridge 184 in the
tissue gap 176. The knife 172 can be configured to be in the
initial position in a proximal, cut-free region of the cartridge
184 and to move to a second, cutting position in a distal, cutting
region of the cartridge 184. The knife 172 can move between the
non-cutting and cutting positions in a variety of ways, but as
shown in this illustrated embodiment, a bottom surface of the
cartridge's longitudinal slot 182 can include a surface feature,
e.g., a camming edge or lip 188, to help move the knife 172 between
its non-cutting and cutting positions. The lip 188 can have a
substantially 90.degree. angle as illustrated in this embodiment,
or the lip 188 can have a non-90.degree. curve or slope to help
more smoothly transition the knife 172 over the lip 188. In the
cartridge's proximal region, the slot 182 can have a depth in the
cartridge 184 that is greater than a depth in the cartridge's
distal region by a depth d1. In this way, when the cutting assembly
distally moves through the slot 182 with the knife 172 in the
initial position, a bottom edge 172a of the knife 172 can contact
the lip 188. Because the pin 180 that attaches the knife 172 to the
pusher bar 178 can be positioned such that the knife's pivot point
is located "above" the lip 188 with the knife 172 in the initial
position, the knife 172 can have adequate leverage to rotate around
the pin 180 in a counter-clockwise direction relative to the pusher
bar 178 and to the end effector as the knife 172 continues its
distal movement past the lip 188 through the end effector, as shown
in FIG. 35.
After rotating from the non-cutting position to the cutting
position, as shown in FIG. 36, the bottom edge 172a of the knife
172 can initially move through the longitudinal slot 182 along a
lip edge 188a forming a bottom surface of the slot 182 in the
cartridge's distal, cutting region. The lip edge 188a can retain
the knife 172 in its cutting position as it translates distally.
Accordingly, the knife 172 in the cutting position in the
cartridge's distal region can be configured to cut tissue in the
tissue gap 176 using the knife's now distally facing cutting edge
174. The pusher bar 178 can be configured to accommodate the
different depths of the longitudinal slot 182 by having a smaller
width in its distal region than at least in an intermediate region
adjacent the distal region, e.g., w.sub.bar being less than
w.sub.bar2 as shown in the pusher bar 166 of FIG. 28, such that the
pusher bar 178 can move through the cartridge 184 without
interfering with any tissue in the tissue gap 176 even after the
knife 172 distally passes the lip 188.
If the cutting assembly is pulled proximally after the knife 172
has contacted the lip 188 and at least started to rotate around the
pin 180 or move along the lip edge 188a, the knife 172 in the
cutting assembly as illustrated can move back to its non-cutting
position from the cutting position proximally past the lip 188.
Depending on the material used to form the knife 172 and the type
of tissue clamped in the tissue gap 176, the tissue in the tissue
gap 176 can provide adequate tension and resistance to move the
knife 172 from the cutting position to the non-cutting position
when the knife 176 is pulled proximally past the lip 188, e.g.,
into the proximal, cut-free region, because the tissue located
proximally past the lip 188 has not been cut and can thus act as a
cam member. Optionally, the cutting assembly can include a rotation
mechanism (not shown), e.g., a rotation spring, a return contact
formed in a wall of the cartridge 184 in the slot 182, etc.,
configured to move the knife 172 from the cutting position to the
non-cutting position when the knife 172 is moved proximally beyond
the lip 188.
A third embodiment of a transector having a cutting element that
moves distally to cut is illustrated in FIGS. 37-40. The cutting
assembly includes a pusher bar 190 having a knife 192 formed at a
distal end of the pusher bar 190. Similar to the cutting assembly
of FIGS. 33-36, the cutting assembly can be configured to move
through a longitudinal slot 196 formed in a staple cartridge 198
and, at least when the knife 192 is in a cutting position, the
knife 192 can be configured to move through a corresponding
longitudinal slot (not shown) formed in an anvil 200. The knife 192
can be integrally formed with the pusher bar 190 and connected to a
main body 190a of the pusher bar 190 via a flexible hinge 194 as
shown. The flexible hinge 194 can be formed from the same material
as the main body 190a and the knife 192, which is preferably rigid
to provide adequate support to the pusher bar 190 as it moves
distally and/or proximally. To make the rigid material of the
pusher bar 190 flexible, the area of the pusher bar 190 forming the
hinge 194 can be treated to become flexible in any way appreciated
by a person skilled in the art, e.g., with heat treatment, with
scoring, etc. In an alternate embodiment illustrated in FIG. 41, a
knife 192' can be an independent element coupled to a pusher bar
190' via a flexible connector element 191 having any configuration
and connected to the pusher bar 190' and the knife 192' in any way
as will be appreciated by a person skilled in the art, e.g., a wire
spot welded to opposed slots formed in the pusher bar 190' and the
knife 192'. The knife 192' can move between positions when the
connector element 191 bends, similar to the knife 192 moving
between positions when the hinge 194 bends, as discussed further
below. A person skilled in the art will appreciate that the
flexible connector element 191 can be mated to the hinge 194 to
provide the hinge 194 with additional structural support.
Referring again to the embodiment of FIGS. 37-40, in an initial,
non-cutting position shown in FIG. 37, the knife 192 can be
configured to be fully retained within the cartridge 198 such that
the knife 192 can distally translate through the cartridge 198 in
the initial position without cutting tissue engaged between the
anvil 200 and the cartridge 198 in the tissue gap 202. The knife
192 can be configured to be in the initial position in a proximal,
cut-free region of the cartridge 198 and to move to a second,
cutting position in a distal, cutting region of the cartridge 198.
The knife 192 can move between the non-cutting and cutting
positions in a variety of ways, but as shown in this illustrated
embodiment, a bottom surface of the cartridge's longitudinal slot
196 can include a surface feature, e.g., a camming edge or lip 204,
similar to the lip 188 of the cartridge 184 of FIGS. 33-36 and
having a sloped, non-90.degree. edge, to help move the knife 192
between its non-cutting and cutting positions. Also similar to the
other cartridge 184, the slot 196 in the cartridge's proximal
region can have a greater depth than in the cartridge's distal
region. In this way, when the cutting assembly distally moves
through the slot 196 with the knife 192 in the initial position, a
distal edge 192a of the knife 192 can contact the lip 204. The
distal edge 192a can include a cutting edge along a partial length
thereof, with a bottom portion of the distal edge 192a closest to
the hinge 194 being more dull than the cutting edge to help prevent
the knife 192 from cutting the lip 204 instead of leveraging
against the lip 204 and moving over the lip 204 as the hinge 194
bends. Although the knife's pivot point at the hinge 194 is located
"below" the lip 204 with the knife 192 in the initial position, the
lip 204 can provide adequate leverage for the hinge 194 to flex and
bend the knife 192 until corresponding mating edges 190b of the
knife 192 and the pusher bar's main body 190a come into contact and
the knife 192 is in its cutting position, as shown in FIGS. 39 and
40. The pusher bar 190 can have a cut-out 190c formed therein
located between the knife 192 and the main body 190c, e.g., above
the hinge 194, to accommodate bending of the hinge 194 and movement
of the knife 192. Tissue engaged in the tissue gap 202 between the
cartridge 198 and the anvil 200 can provide adequate tension to
hold the knife 192 in the cutting position during distal
translation. The hinge 194 can optionally be configured to
permanently deform when the knife 192 bends back against the main
body 190a to help ensure that the knife 192 stays in the cutting
position. Alternative, or in addition, one or both of the mating
edges 190b can optionally include at least one mating feature,
e.g., a snap lock, an adhesive, etc., to hold the mating edges 190b
together when they move into close enough contact. With the knife
192 rotated in a clockwise direction from the non-cutting position
to the cutting position, a bottom edge 190d of the pusher bar 190
can move through the longitudinal slot 196 along a lip edge 204a
forming a bottom surface of the slot 196 in the cartridge's distal,
cutting region. Accordingly, the knife 192 in the cutting position
in the cartridge's distal region can be configured to cut tissue in
the tissue gap 202 using the knife's now distally facing cutting
edge 192a.
Similar to that discussed above, if the cutting assembly is pulled
proximally after the knife 192 has contacted the lip 204 and the
hinge 194 has at least started to bend, the knife 192 in the
cutting assembly as illustrated can move back to its non-cutting
position from the cutting position. The cartridge 198 in this
illustrated embodiment includes at least one return contact 206
formed in or otherwise coupled to a wall of the slot 190 that can
have any configuration, as will be appreciated by a person skilled
in the art, to engage the knife 192 and push the knife 192 back to
its non-cutting position as the knife 192 moves proximally past the
return contact 206. The knife 192 can have a corresponding return
contact formed thereon or otherwise coupled thereto, e.g., a
protrusion, that is configured to engage the slot's return contact
206 to help move the knife 192 from the cutting position to the
non-cutting position.
As mentioned above, in some embodiments the cutting element can
move proximally through a transector to cut tissue. In such
embodiments, the cutting assembly can have an initial, unassembled
configuration where the cutting element can be an element
independent from a pusher bar configured to move the cutting
element through a distal, cutting region of the transector's end
effector. Generally, the pusher bar can move distally through the
end effector and fasteners can be applied to tissue in the distal,
cutting region. Having moved distally far enough through the end
effector, the pusher bar can engage the cutting element disposed at
a distal end of the end effector and it can be pulled proximally to
move the pusher bar with the cutting element attached thereto
through the end effector. Pulling the cutting element proximally
can keep elements of the cutting assembly linearly aligned and
reduce chances of any part of the cutting assembly buckling.
One embodiment of a transector having a cutting element that moves
proximally is illustrated in FIGS. 42-44. The cutting assembly
includes a knife 208 and a pusher bar 210. The knife 208 and the
pusher bar 210 can be disconnected from each other in an initial,
non-cutting position before at least the knife 208 translates
through an end effector including opposed first and second jaws
212, 218. Generally, the pusher bar 210 can move distally through a
longitudinal slot 214 in the first jaw 212, as shown in FIG. 42,
and it can "grab" the knife 208 when the pusher bar 210 encounters
the knife 208 in a distal portion 214a of the slot 214. The pusher
bar 210 can be actuated in any way to move the pusher bar 210
distally through the slot 214, as shown in FIG. 42. The pusher bar
210 with the knife 208 attached thereto can be moved proximally
through the slot 214 to allow the knife 208 to cut tissue engaged
in a distal region of a tissue gap 216 between the first and second
jaws 212, 218, as shown in FIG. 43, but not in a proximal, cut-free
region of the first and second jaws 212, 218, as shown in FIG. 44.
In an exemplary embodiment, one or more fasteners can be applied to
tissue in the distal region of the tissue gap 216 before the knife
208 cuts the tissue, e.g., the pusher bar 210 or other fastener
driving mechanism ejects one or more fasteners from the end
effector, although one or more fasteners can be applied to the
tissue as the tissue is cut. Separately cutting tissue and applying
fasteners to the tissue can allow more force to be applied to each
of tissue cutting and tissue fastening.
The knife 208 and the pusher bar 210 can generally be configured
similar to knives and pusher bars discussed above, although the
knife 208 and the pusher bar 210 can have corresponding, respective
catch mechanisms 208a, 210a formed thereon or otherwise coupled
thereto to help the pusher bar 210 "grab" the knife 208. The catch
mechanisms 208a, 210a can each have a variety of configurations.
The knife's catch mechanism 208a can include a hole formed through
the knife 208, while the pusher bar's catch mechanism 210a can
include a flex catch configured to engage the hole to attach the
knife 208 to the pusher bar 210. The pusher bar's flex catch can be
formed in any way, such as by pressing out a tongue in material
such as sheet metal that forms the pusher bar 210. The knife 208
can optionally include a flex member 208b extending from the hole
as part of the knife's catch mechanism to help the pusher bar's
catch mechanism 210a engage the hole. The flex member 208b can be
formed similar to the pusher bar's flex catch.
The knife 208 can be pre-positioned in the initial position within
the first jaw 212 at the distal portion 214a of the slot 214, while
the pusher bar 210 can be pre-positioned 208 in the initial
position anywhere proximal to the knife 208, e.g., proximal to a
proximal end (not shown) of the slot 214. In the initial position,
the knife 208 can be positioned such that a proximal cutting edge
208c of the knife 208 is disposed within the first jaw 212 such
that the cutting edge 208c cannot cut tissue engaged in the tissue
gap 216 between the jaws 212, 218. Because the knife 208 moves
proximally through the end effector to cut tissue, the cutting edge
208c is formed on a proximal side of the knife 208. The knife 208
in the initial position can also be positioned substantially at a
distal end of the first jaw 212 with its distal, non-cutting side
208d positioned adjacent a bottom surface 214a of the slot 214 and
its proximal cutting edge 208c facing the tissue gap 216. Such
positioning can help move the cutting edge 208c into the tissue gap
216 when the pusher bar 210 engages the knife 208 and pulls the
knife 208 proximally through the slot 214. A proximal cut-out 208e
formed in the knife's distal side 208d can abut a distal-facing
edge 220a of a step 220 formed in the slot 214. The step's
distal-facing edge 220a can act as a camming edge or lip configured
to rotate the knife 208 in a clockwise direction from the initial,
non-cutting position to the cutting position when the knife 208 is
engaged and pulled proximally by the pusher bar 210. Accordingly,
the proximal cut-out 208e and the step's distal-facing edge 220a
can have corresponding complementary sizes and shapes. The knife
208 can optionally be removably secured in the initial position in
the slot 214 in any way appreciated by a person skilled in the art,
such as with a releasable catch mechanism formed on or otherwise
coupled to any one or more of the knife 208, the step 220, and the
slot 214.
As shown in FIG. 43, when the pusher bar 210 couples to the knife
208 and pulls the knife 208 proximally over the step's
distal-facing edge 220a, the knife 208 can be configured to
translate along the slot's bottom surface 214, also a top surface
of the step 220, with the knife's cutting edge 208c extending into
the tissue gap 216 and into a longitudinal slot formed in the
second jaw or anvil 218. The knife 208 can thus cut tissue in the
distal region of the end effector because the step 220 can be
positioned within the slot 214 to correspond with the end
effector's distal region. When the knife 208 reaches a proximal
edge 220b of the step 220, the knife 208 can rotate substantially
back to its initial, non-cutting position, as shown in FIG. 44. In
this way, when the knife 208 substantially returns to its initial,
non-cutting position proximally beyond the step's proximal edge
220b, the knife 208 can be configured to not cut tissue in the
proximal, cut-free region of the end effector. The proximal motion
of the pusher bar 210 can move the knife 208 from the cutting
position to the non-cutting position such that the knife's distal
side 208d moves back into contact with the slot's bottom surface
214a. Optionally, the first and/or second jaw can include a camming
edge or lip (not shown) to help move the knife 208 from the cutting
position to the non-cutting position. For non-limiting example, the
slot 214 in the first jaw 212 can only extend through a
tissue-contacting surface of the first jaw 212 in the distal
region, similar to the slot 156 in the staple cartridge 154 of
FIGS. 23-25, such that a proximal edge of the slot 214 in the
tissue-contacting surface can help urge the knife 208 to the
non-cutting position.
A second embodiment of a transector having a cutting element that
moves proximally to cut is illustrated in FIGS. 45-47. The cutting
assembly includes a knife 222 and a pusher bar 224. The cutting
assembly is generally configured as discussed above except that the
knife 222 can be configured as a two-part member including distal
and proximal members 222a, 222b connected together with a
connection mechanism such as a hinge 226. The hinge 226 can include
any type of hinge, e.g., a pivoting pin. The knife 222 can be
positioned in an initial, non-cutting position in an end effector
similar to the knife 208 of FIGS. 42-44 with mating edges 228 of
the proximal and distal members 222a, 222b positioned on a slot's
bottom surface such that the knife 222 can be in a substantially
flat or linear position with longitudinal axes of the proximal and
distal members 222a, 222b substantially aligned. In this
embodiment, the slot's bottom surface need not include a step as in
the embodiment of FIGS. 42-44 because the knife 222 can move into a
tissue gap by bending at the hinge 226.
The pusher bar 224 can move distally through the end effector and
attach to the knife 222 using a catch mechanism, e.g., with a flex
catch 230 configured to engage a hole 232 formed in the knife's
distal member 222b. Proximal motion of the pusher bar 224 after the
pusher bar 224 has attached to the knife's distal member 222b can
apply a force to the distal member 222b, thereby bending the knife
222 at the hinge 226, as shown in FIG. 45, to move the mating edges
228 together and move the knife 222 from the non-cutting position
to the cutting position, as shown in FIG. 47. The knife 222 can
move back to the non-cutting position for the knife's translation
through the end effector's proximal, non-cutting region in any way,
as will be appreciated by a person skilled in the art. For
non-limiting example, substantially at an intersection between the
distal, cutting region and the proximal, non-cutting region of the
end effector, the end effector can include at least one return
contact formed in the wall of the slot through which the cutting
assembly translates in the end effector, similar to that as
discussed above regarding FIG. 40. As another non-limiting example,
the end effector can include a stop mechanism to stop proximal
translation of at least the knife 222 through the end effector,
e.g., a camming edge or lip formed at a proximal edge of the slot
at a tissue-contacting surface of the end effector.
Because the transector has a distal, cutting region and a proximal,
cut-free region, the transector can apply the staples 96 and form
the stomach opening 94 at a distance, equal to the longitudinal
length d.sub.p, from the edge of the stomach 40 at the antrum 40a,
as shown in FIG. 15. The remainder of the stomach 40 between the
opening 94 and the angle of His 40b can be transected in any way,
as will be appreciated by a person skilled in the art, using the
same and/or different transector than that used to form the opening
94 and apply the staples 96. In an exemplary embodiment, as shown
in FIG. 48, a second transection device 234, such as a linear
surgical stapler, can be introduced into the patient 10 through any
opening, e.g., through an abdominal access hole, a natural orifice,
etc., with or without a single or multiple port access device
positioned therein. In an exemplary embodiment, the second
transection device 234 can be inserted through the opening 94 in
the stomach 40, and it can be used to cut and secure the stomach 40
along a transection "line" in a direction from the opening 94 to
the angle of His 40b, using the sizer 106 as a guide until the
angle of His 40b is breached. Using a conventional linear stapler
instead of a transactor having a proximal cut-free region can allow
for fewer strokes of the stapler to complete the transection.
FIG. 49 shows the stomach 40 having a transection "line" 235 formed
therein where a partial length of the stomach 40 has been
transected. The transection "line" 325 can generally be an opening
in the stomach 40 that is closed or sealed using one or more
securing elements, e.g., two rows of staples on either side of the
opening. The stomach 40 can thereby be separated by the transection
"line" 325 between the lesser curvature 40c and the greater
curvature 91 to form a gastric tube or stomach sleeve 327 along the
lesser curvature 40c that drains into the antrum 40a. Such a
transection can separate the stomach fundus from an area of the
stomach 40 substantially near the patient's esophagus and allow the
fundus to retain fluid communication with the patient's pylorus 93,
and more specifically, with the patient's pyloric valve.
In an alternate embodiment of a stomach transection, a single
transection device can be used to transect a desired length of the
stomach 40 in a Magenstrasse and Mill procedure without having to
reposition the transector from its initial position engaging the
stomach 40. In an exemplary embodiment shown in FIG. 50, an
extended length transection device 236 can be positioned relative
to the stomach 40 with an end effector 238 of the extended length
transection device 236 extending across a length of the stomach 40
between the antrum 40a and the angle of His 40b. A person skilled
in the art will also appreciate that an extended-length end
effector similar to the extended-length end effector 238 can be
used with any transactor described herein. A proximal end 238a of
the end effector 238 can be positioned substantially at the antrum
40a with the end effector 238 extending toward the angle of His 40b
such that a distal end 238b of the end effector 238b can extend
distally beyond the angle of His 40b. The end effector 238 can have
any shape, but in an exemplary embodiment it can be arcuate as
shown to better approximate a desired transection line that would
otherwise be hand-estimated through repeated positioning and
actuating of one or more transection devices. The end effector 238
can also have any size and any longitudinal length, e.g., at least
about 180 mm. The end effector 238 can have a proximal, cut-free
region and a distal, cutting region as discussed above. In this
way, the extended length transactor 236 can be used to transect the
stomach 40 substantially as shown in FIG. 49 in one or more
actuation strokes without having to reposition the end effector 238
of the transactor 236 or reload additional fasteners into the end
effector 238, thereby making the surgical procedure faster and
safer. Using the extended length transection device 236 to transect
the stomach 40 can also reduce the need to retract the patient's
liver and/or the need to provide counter traction with a grasper
during the transection.
One embodiment of the extended length transector 236 is shown in
FIGS. 51-53. Generally, the transector 236 can include a proximal,
handle portion 254 having an elongate shaft 256 extending distally
therefrom, with the end effector 238 located at a distal end of the
elongate shaft 256. One or more staple cartridges each having a
plurality of staples loaded therein can be loaded into the end
effector 238, although any type of fasteners can be used as
mentioned above. If multiple staple cartridges are loaded into the
end effector 238, the staple cartridges can have the same or
different longitudinal lengths and the same or different size
staples from any other cartridge loaded in the end effector 238. In
this way, variable thicknesses of the stomach 40 can be
accommodated by the transector 236. In some embodiments, the
fasteners can be disposed in an end effector of a transector
without a cartridge such that the transactor is a single use
device.
The jaws 242, 244 can be drawn together with tissue engaged in at
least a portion of a tissue gap 248 between the opposed jaws 242,
244, e.g., by actuating a first, clamping handle 250 in the handle
portion 254. However, before clamping tissue to be transected
between opposed, first and second jaws 242, 244 of the end effector
238, the end effector's position within a patient's body can be
adjusted to desirably position the end effector 238 adjacent tissue
to be cut and fastened. The transector 236 can include a rotation
knob 252 configured to rotate the end effector 238 and optionally
the elongate shaft 256 relative to the handle portion 254 to help
position the end effector 238 in a desired position with a body of
a patient. The transactor 236 can also or instead include a flex
region 258 located at a proximal end 238b of the end effector 238
that can be configured to bend the end effector 238 relative to the
elongate shaft 256. While the flex region 258 can be flexed by
actuating a control mechanism at the transector's handle portion
254, a person skilled in the art will appreciate that the flex
region 258 can be passively flexed by positioning the end effector
238 against a surface to cause flexion. A person skilled in the art
will also appreciate that the elongate shaft 256 and/or the end
effector 238 can include one or more flex regions or flexible
joints, and that each can be configured in any way, as discussed
above. As shown in an alternate embodiment of a transactor end
effector 238' in FIG. 54, the end effector 238' can include a
flexible joint in the form of a plurality of slots or notches 239
formed in the end effector 238' such that the end effector 238' has
a reduced cross-section where each of the notches 239 are formed.
An elongate shaft from which the end effector 238' extends can
alternatively, or in addition, include similar slots or
notches.
To accommodate the proximal, cut-free region in the end effector
238, the transector 236 can be configured with a cutting element
and a staple driver disposed in an initial, non-cutting position at
a distal end 238a of the end effector 236. As shown in FIG. 53, the
cutting element and the staple driver can be in the form of an
I-beam 240 configured to cut tissue using a cutting edge on a
proximal side of the I-beam 240 and to drive staples, although, as
will be appreciated by a person skilled in the art, the cutting
element and the staple driver can be separate elements. The I-beam
240 cab be disposed in one of the first and second jaws 242, 244,
and the other one of the jaws 242, 244 can have an opening 246 at a
distal end thereof to receive the I-beam 240 when the jaws 242, 244
are moved from an open to a closed position. The stomach's angle of
His can provide clearance space in the patient that can provide
adequate space for the I-beam 240 at the distal end 238a of the end
effector 236 to engage the opening 246. A person skilled in the art
will appreciate that the end effector 238 can be augmented with
buttress material to provide it with additional structural
support.
The I-beam 240 can be configured to translate along a partial
longitudinal length of the end effector 238 in any way appreciated
by a person skilled in the art, e.g., by actuating a driving handle
260 in the handle portion 254. Actuation of the driving handle 260
can proximally pull the I-beam 240 along the end effector 238 to
fasten and/or cut tissue in the tissue gap 248, although in some
embodiments the transector 236 can be distally driven rather than
proximally driven to cut tissue. Movement of the I-beam 240 through
the end effector 238 can also help reduce flex of the jaws 242, 244
if a large amount of tissue is engaged between the jaws 242, 244.
Actuation of the driving handle 260 can proximally pull the I-beam
240 in any way appreciated by a person skilled in the art, such as
by winding a wire 264 connected at its respective terminal ends to
a reel 262 in the handle portion 254 and to the I-beam 240 such
that winding of the wire 264 around the reel 262 proximally moves
the I-beam 240 through the end effector 238.
The I-beam 240 can be configured to cut tissue engaged in the
distal, cutting region of the end effector 238 without cutting
tissue engaged in the proximal, non-cutting region of the end
effector 238 in a variety of ways. For non-limiting example,
complete actuation of the driving handle 260 can be configured to
move the I-beam 240 only a partial distance along the length of the
end effector 238. As another non-limiting example, the end effector
238 can include a stop mechanism located substantially at an
intersection of the distal and proximal regions and configured to
stop proximal movement of the I-beam 240 once the I-beam contacts
the stop mechanism. One embodiment of a stop mechanism includes a
proximal edge of the channel 246 through which the I-beam 240
translates in one of the jaws 242, 246 and/or in a channel in which
the I-beam 240 moves in the jaw to which it is attached.
However performed, the transection can be visualized using at least
one scoping device inserted through any opening, as discussed
herein. For non-limiting example only, the surgeon can visualize
above and/or underneath the stomach 40 to determine if a desired
path of transection is clear or readily cleared of tissue and/or
other debris. The surgeon can place one or more draining devices in
the stomach fundus following the transection, e.g., along a greater
curvature of the stomach sleeve formed by the transection. If used,
the sizer 106 can be removed from the stomach 40 at any time during
the surgical procedure, but in an exemplary embodiment it is
removed from the patient 10 by retracting it through the patient's
mouth 108 after the stomach 40 has been transected and inspected
via scoping device visualization for any uncorrected and
potentially dangerous irregularities, e.g., improperly bent
staples, improperly placed staples, untied sutures, etc.
The surgeon can optionally secure the transected stomach, e.g.,
along the stapled or otherwise secured cut edge of the fundus,
using any one or more supplemental securing elements in any
combination to help better secure the transection and/or reduce
bleeding. The supplemental securing elements are preferably
biocompatible and can optionally be bioabsorbable such that the
supplemental securing elements can dissolve in the patient 10 over
time as the transection heals. Non-limiting embodiments of a
surgical stapler than can apply staples with bioabsorbable pledgets
can be found in previously filed U.S. patent application Ser. No.
11/541,374 of Hess et al. filed on Sep. 29, 2006 and entitled
"Surgical Staples Having Dissolvable, Bioabsorbable Or
Biofragmentable Portions And Stapling Instruments For Deploying The
Same," which is hereby incorporated by reference in its
entirety.
At the conclusion of a gastroplasty, any access holes formed in a
patient can be closed in any way and in any order as will be
appreciated by a person skilled in the art, such as by suturing the
openings.
The patient 10 can optionally be provided with a drug and/or device
that suppresses appetite that can work in conjunction with the
stomach sleeve to help the patient 10 lose weight. Such a drug or
device can be provided to the patient 10 at the end of the
gastroplasty and/or in a subsequent surgical procedure. A
non-limiting embodiment of an implantable appetite suppressant
device is available from Duocore, Inc. of Ramat-Hasharon,
Israel.
A gastroplasty procedure described herein can optionally be
combined with one or more other surgical procedures. For
non-limiting example, the gastroplasty can be combined with a
transoral minimally invasive surgical procedure, non-limiting
examples of which, e.g., creating a gastroenteroanastomosis or
enteroenteroanastomosis, can be found in U.S. Patent Application
No. 2006/0271075 filed May 18, 2006 and entitled "Double Loop
Gastric Bypass Procedure," which is hereby incorporated by
reference in its entirety. As another non-limiting example, the
gastroplasty can be performed as a first stage of a two stage
surgical procedure where a second stage, e.g., a duodenal switch, a
Roux-en-Y procedure, etc., can be performed immediately after the
gastroplasty or in a subsequent surgical procedure.
A person skilled in the art will appreciate that the present
invention has application in conventional endoscopic and open
surgical instrumentation as well application in robotic-assisted
surgery.
The devices disclosed herein can also be designed to be disposed of
after a single use, or they can be designed to be used multiple
times. In either case, however, the device can be reconditioned for
reuse after at least one use. Reconditioning can include any
combination of the steps of disassembly of the device, followed by
cleaning or replacement of particular pieces and subsequent
reassembly. In particular, the device can be disassembled, and any
number of the particular pieces or parts of the device can be
selectively replaced or removed in any combination. Upon cleaning
and/or replacement of particular parts, the device can be
reassembled for subsequent use either at a reconditioning facility,
or by a surgical team immediately prior to a surgical procedure.
Those skilled in the art will appreciate that reconditioning of a
device can utilize a variety of techniques for disassembly,
cleaning/replacement, and reassembly. Use of such techniques, and
the resulting reconditioned device, are all within the scope of the
present application.
One skilled in the art will appreciate further features and
advantages of the invention based on the above-described
embodiments. Accordingly, the invention is not to be limited by
what has been particularly shown and described, except as indicated
by the appended claims. All publications and references cited
herein are expressly incorporated herein by reference in their
entirety.
One skilled in the art will appreciate further features and
advantages of the invention based on the above-described
embodiments. Accordingly, the invention is not to be limited by
what has been particularly shown and described, except as indicated
by the appended claims. All publications and references cited
herein are expressly incorporated herein by reference in their
entirety.
* * * * *
References